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| Dockets Entered
On November 22, 2006
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 2004E-0316
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| Patent Extension for ERTACZO (sertaconazole nitrate), U.S. Patent No. 5,135,943
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006F-0409
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| Safe Use of Cetylpyridinium Chloride as an Antimicrobial Agent in a Pre-chiller or Post-chiller Solution for Application to Raw Poultry Carcasses (FAP 6A4767)
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| 2006N-0067
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| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006P-0085
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| To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006V-0474
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| Variance for the Poalomar Lux1540 handpiece
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| 1978N-0065
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| Skin Bleaching Drug Products
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| EC 89
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| Dr. ADAM BODIAN
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| Vol #:
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| 14
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| EC 90
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| Dr. Kevin Stein
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| Vol #:
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| 14
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| 2004E-0316
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| Patent Extension for ERTACZO (sertaconazole nitrate), U.S. Patent No. 5,135,943
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| CEP 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| EC 59
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| American College of Emergency Physicians
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| Vol #:
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| 3
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| EC 60
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| Division of Medical Ethics, Harvard Medical School
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| Vol #:
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| 3
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| EC 61
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| Ms. Nancy King
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| Vol #:
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| 3
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| EC 2024
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| Mrs. Colleen Domme
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| Vol #:
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| 8
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| EC 2025
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| Mrs. Leane VanderPutten
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| Vol #:
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| 8
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| EC 2026
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| Mrs. Christine Inglin
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| Vol #:
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| 8
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| EC 2027
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| Mr. Ronald Coleman
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| Vol #:
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| 8
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| EC 2028
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| Mr. Anthony Adams
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| Vol #:
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| 8
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| EC 2029
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| Mrs. Rosemary McNeill
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| Vol #:
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| 8
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| EC 2030
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| GLHS
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| Vol #:
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| 8
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| EC 2031
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| Mr. Joseph Collison
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| Vol #:
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| 8
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| EC 2032
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| Mr. Eric Johnston
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| Vol #:
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| 8
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| EC 2033
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| Mr. Gregory and Rebecca Nagel
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| Vol #:
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| 8
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| EC 2034
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| Mrs. Karen May
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| Vol #:
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| 8
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| EC 2035
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| Mrs. Kristy Kordsmeier
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| Vol #:
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| 8
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| EC 2036
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| Mrs. Mary Kustra
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| Vol #:
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| 8
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| EC 2037
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| Ms. Mary Quinn
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| Vol #:
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| 8
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| EC 2038
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| Miss. Amber Ford
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| Vol #:
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| 8
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| EC 2039
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| Mrs. Patricia Crew
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| Vol #:
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| 8
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| EC 2040
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| Miss. Cristina Abel
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| Vol #:
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| 8
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| EC 2041
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| Mrs. Marie Hoffman, RN
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| Vol #:
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| 8
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| EC 2042
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| ACES School
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| Vol #:
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| 8
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| EC 2043
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| Mrs. Melissa Shanks
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| Vol #:
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| 8
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| EC 2044
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| Mr. Lawrence Flick
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| Vol #:
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| 8
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| EC 2045
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| Mrs. Grace Guzowski
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| Vol #:
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| 8
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| EC 2046
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| Mrs. Jenny Nelson
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| Vol #:
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| 8
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| EC 2047
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| Mr. Philip O'Brien
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| Vol #:
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| 8
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| EC 2048
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| Mrs. Anne Gwynn
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| Vol #:
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| 8
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| EC 2049
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| Mrs. Janine Gaglio
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| Vol #:
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| 8
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| EC 2050
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| Walla Walla Clinic
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| Vol #:
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| 8
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| EC 2051
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| Miss. pamela juergens
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| Vol #:
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| 8
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| EC 2052
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| Mrs. Anne-Marie Roberts
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| Vol #:
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| 8
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| EC 2053
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| Mr. Lawrence Banasky
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| Vol #:
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| 8
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| EC 2054
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| lutheran hospital of indiana
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| Vol #:
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| 8
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| EC 2055
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| Ms. Mary Ishag
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| Vol #:
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| 8
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| EC 2056
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| Dr. Steven Pilkington
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| Vol #:
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| 8
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| EC 2057
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| Mrs. LINDA MAURER
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| Vol #:
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| 8
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| EC 2058
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| Mrs. Patricia Kinney
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| Vol #:
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| 8
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| EC 2059
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| Mrs. Rosemary Jacobs
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| Vol #:
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| 8
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| EC 2060
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| Genesis
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| Vol #:
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| 8
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| EC 2061
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| Mr. Gary Jacobs
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| Vol #:
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| 8
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| EC 2062
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| Mr. Steven Reisiger
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| Vol #:
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| 8
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| EC 2063
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| Miss. Margaret Jacobs
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| Vol #:
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| 8
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| EC 2064
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| Mr. George Kriegl
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| Vol #:
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| 8
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| EC 2065
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| Mrs. Marla Olsen
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| Vol #:
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| 8
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| EC 2066
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| Mrs. Mary Clare Peck
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| Vol #:
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| 8
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| EC 2067
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| Mr. Terrence Mraz
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| Vol #:
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| 8
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| EC 2068
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| Mr. Anthony L. Pometto III
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| Vol #:
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| 8
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| EC 2069
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| Mr. Tom Kustner
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| Vol #:
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| 8
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| EC 2070
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| Miss. Meghan Mac-Rhyann
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| Vol #:
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| 8
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| EC 2071
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| Mr. Anthony Gick
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| Vol #:
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| 8
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| EC 2072
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| Mrs. Carol Gick
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| Vol #:
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| 8
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| EC 2073
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| Mr. Raymon Carlson
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| Vol #:
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| 8
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| EC 2074
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| Mrs. Diane Crist
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| Vol #:
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| 8
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| EC 2075
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| Mrs. Joel Jensen
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| Vol #:
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| 8
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| EC 2076
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| Mrs. Kathy Martuscelli
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| Vol #:
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| 8
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|
| 2006F-0409
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| Safe Use of Cetylpyridinium Chloride as an Antimicrobial Agent in a Pre-chiller or Post-chiller Solution for Application to Raw Poultry Carcasses (FAP 6A4767)
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| EC 3
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| Food
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| Vol #:
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| 1
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| 2006N-0067
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| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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| EC 3
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| US Fish and Wildlife Service
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| Vol #:
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| 1
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| C 278
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| Dr. D. Boettcher
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| Vol #:
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| 26
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| C 279
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| R. Huffman
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| Vol #:
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| 26
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| C 280
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| J. Trustone
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| Vol #:
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| 26
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| C 281
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| D. Stockin, MPH
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| Vol #:
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| 26
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| C 282
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| J. Presley, PhD
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| Vol #:
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| 26
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| C 283
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| J. Thompson
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| Vol #:
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| 26
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| C 284
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| D. Veilleux
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| Vol #:
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| 26
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| C 285
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| S. Patterson
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| Vol #:
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| 26
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| C 286
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| M. Brake
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| Vol #:
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| 26
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| C 287
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| D. Barbier
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| Vol #:
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| 26
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| C 288
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| B. Scott, RDH
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| Vol #:
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| 26
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| C 289
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| Dr. A. Ford
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| Vol #:
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| 26
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| C 290
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| J. Ross
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| Vol #:
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| 26
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| C 291
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| C. Peeples
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| Vol #:
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| 26
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| C 292
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| R. Briggs
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| Vol #:
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| 26
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| C 293
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| G and M Pearson
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| Vol #:
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| 26
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| C 294
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| P. Kjellstad
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| Vol #:
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| 26
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| C 295
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| L. Piatt, MSN, RN,
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| Vol #:
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| 26
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| C 296
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| L. Salterberg
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| Vol #:
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| 26
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| C 297
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| D Epstein and D. Seborer
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| Vol #:
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| 26
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| C 298
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| S. Huff
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| Vol #:
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| 26
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| C 299
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| C. Darling
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| Vol #:
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| 26
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| C 300
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| W. Harris, M.D.
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| Vol #:
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| 26
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| C 301
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| E. Rhodes
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| Vol #:
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| 26
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| C 302
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| R. Grupp
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| Vol #:
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| 26
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| C 303
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| L. Hays
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| Vol #:
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| 26
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| C 304
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| S. Ferris
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| Vol #:
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| 26
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| C 305
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| R. Gunnigle
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| Vol #:
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| 26
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| C 306
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| C. Oss
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| Vol #:
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| 26
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| C 307
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| A. Skillings
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| Vol #:
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| 26
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| C 308
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| L. Pruett, RDH
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| Vol #:
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| 26
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| C 309
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| A. Chang
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| Vol #:
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| 26
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| C 310
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| F. Schubert
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| Vol #:
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| 26
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| C 311
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| L. Thomas
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| Vol #:
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| 26
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| C 312
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| P. Swint
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| Vol #:
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| 26
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| C 313
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| J. Hawthorne
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| Vol #:
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| 26
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| C 314
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| Dr. R. McGinn
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| Vol #:
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| 26
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| C 315
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| V. Williams
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| Vol #:
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| 26
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| C 316
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| E. Brandt
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| Vol #:
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| 26
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| C 317
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| V. Williams
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| Vol #:
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| 26
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| C 318
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| J. Marcus
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| Vol #:
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| 26
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| C 319
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| B. Adler
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| Vol #:
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| 26
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| C 320
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| C. HAssett
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| Vol #:
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| 26
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| C 321
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| R. Waltman
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| Vol #:
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| 26
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| C 322
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| K. Maestas
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| Vol #:
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| 26
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| C 323
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| C. Geyer
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| Vol #:
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| 26
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| C 324
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| P. Parton
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| Vol #:
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| 26
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| C 325
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| D. Green
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| Vol #:
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| 26
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| C 326
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| M. Kauderer
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| Vol #:
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| 26
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| C 327
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| C. Tuttle
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| Vol #:
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| 26
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| C 328
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| K. Burns
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| Vol #:
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| 26
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| C 329
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| D. Miller, J.D.
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| Vol #:
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| 26
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| C 330
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| P. Moller
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| Vol #:
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| 26
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| C 331
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| J. Parfitt
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| Vol #:
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| 26
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| C 332
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| S. Mohmand
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| Vol #:
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| 26
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| C 333
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| T. Irvin
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| Vol #:
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| 26
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| C 334
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| D. Rhoades
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| Vol #:
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| 26
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| C 335
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| M. Block
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| Vol #:
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| 26
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| C 336
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| S. Rossi
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| Vol #:
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| 26
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| C 337
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| R. Fischer, D.D.S.
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| Vol #:
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| 26
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| C 338
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| H. Downing
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| Vol #:
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| 26
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| C 339
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| B. Sachau
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| Vol #:
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| 26
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| C 340
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| M. Cochran
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| Vol #:
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| 26
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| C 341
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| Dr. D. Cook, DDS, SC
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| Vol #:
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| 26
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| C 342
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| M. Haines
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| Vol #:
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| 26
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| C 343
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| N. BAllantyne
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| Vol #:
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| 26
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| C 344
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| No siganture
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| Vol #:
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| 26
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| C 345
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| A. Thomson
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| Vol #:
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| 26
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| C 346
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| S. Michetti
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| Vol #:
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| 26
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| C 347
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| S. Simmons
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| Vol #:
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| 26
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| C 348
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| J. Brown
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| Vol #:
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| 26
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| C 349
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| S. Stratton, DC
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| Vol #:
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| 26
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| C 350
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| V. Vazin
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| Vol #:
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| 26
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| C 351
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| L. Simon
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| Vol #:
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| 26
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| C 352
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| K. Lanford
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| Vol #:
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| 26
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| C 353
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| Dr. J. Echols
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| Vol #:
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| 26
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| C 354
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| K. Ornstein
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| Vol #:
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| 26
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| C 355
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| E. Gioumousis
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| Vol #:
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| 26
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| C 356
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| Dr. D. Warner
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| Vol #:
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| 26
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| C 357
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| M. Fenci
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| Vol #:
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| 26
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| C 358
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| J. Delgado
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| Vol #:
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| 26
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| C 359
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| E. Krinsky
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| Vol #:
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| 26
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| C 360
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| Dr. N. Meyer
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| Vol #:
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| 26
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| C 361
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| L. Hiler
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| Vol #:
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| 26
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| C 362
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| B. Dziuban
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| Vol #:
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| 26
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| C 363
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| Dr. D. Schmidt
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| Vol #:
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| 26
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| C 364
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| D. Liston
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| Vol #:
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| 26
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| C 365
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| H. Reinert
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| Vol #:
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| 26
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| C 366
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| L. Evanston
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| Vol #:
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| 26
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| C 367
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| J. Lewis
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| Vol #:
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| 26
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| C 368
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| F. Wasson
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| Vol #:
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| 26
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| C 369
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| O. Woodward
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| Vol #:
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| 26
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| C 370
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| K. Calabrese
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| Vol #:
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| 26
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| C 371
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| M. Jackson, DDS
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| Vol #:
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| 26
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| C 372
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| S. Alcantara
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| Vol #:
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| 26
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| C 373
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| B. Bills
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| Vol #:
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| 26
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| C 374
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| P. Windham
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| Vol #:
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| 26
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| |
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| C 375
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| A. KArimian, PhD
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| Vol #:
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| 26
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| |
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| C 376
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| N. Aleem
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| Vol #:
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| 26
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| |
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| C 377
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| DAMS, Intl
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| Vol #:
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| 26
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|
| | | | | | | | |
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| |
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| C 378
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| DAMS, Intl
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| Vol #:
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| 26
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| |
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| C 379
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| A. Orlove
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| Vol #:
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| 26
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| |
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| C 380
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| M. May
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| Vol #:
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| 26
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| |
|
|
| C 381
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| DAMS, Intl
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| Vol #:
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| 26
|
| |
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| C 382
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| DAMS, Intl
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| Vol #:
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| 26
|
| |
|
|
| C 383
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| J. Alpizar
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| Vol #:
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| 26
|
| |
|
|
| C 384
|
| DAMS, Intl
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| Vol #:
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| 26
|
| |
|
|
| C 385
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| P. Gioumousis
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| Vol #:
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| 26
|
| |
|
|
| C 386
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| P. Robertson, BHSc
|
| Vol #:
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| 26
|
| |
|
|
| C 387
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| S. Doolittle, DVM
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| Vol #:
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| 26
|
|
| |
|
| 2006P-0085
|
| To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements
|
| |
|
|
| EC 8
|
| Children's Hospital, Boston
|
| Vol #:
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| 2
|
| |
|
|
| EC 9
|
| Dr. Joseph Piatt, Jr., MD, FAAP
|
| Vol #:
|
| 2
|
| |
|
|
| EC 10
|
| Dr. Bruce Kaufman, MD
|
| Vol #:
|
| 2
|
| |
|
|
| EC 11
|
| Ms. Sheila Addis
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0223
|
| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
|
|
|
|
|
|
|
|
|
| EC 714
|
| Mrs. Katherine Huffmire
|
| Vol #:
|
| 5
|
| |
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| EC 416
|
| Ms. Heather Smith
|
| Vol #:
|
| 7
|
| |
|
|
| 2006V-0474
|
| Variance for the Poalomar Lux1540 handpiece
|
| |
|
|
| ACK 1
|
| FDA/DDM to Palomar Medical Technologies, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| VAR 1
|
| Palomar Medical Technologies, Inc.
|
| Vol #:
|
| 1
|
|
|
