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| Dockets Entered
On March 11, 2005
Table of Contents
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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|
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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|
|
| 2003N-0528
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| Revision of the Requirements for Spore-Forming Microorganisms
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|
|
| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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|
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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|
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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|
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
| RPT
264
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| Medical Research Institute
|
| Vol #:
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| 193
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|
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| RPT
265
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| Artjen Complexus Holdings Corp.
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| Vol #:
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| 194
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|
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| RPT
266
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| Kaneka Corporation
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| Vol #:
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| 195
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|
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| RPT
267
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| Kaneka Corporation
|
| Vol #:
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| 198
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|
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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|
|
| LET
15575
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| Enzymatic Therapy
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| Vol #:
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| 137
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|
|
| LET
15576
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| Nature's Way Products, Inc.
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| Vol #:
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| 137
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|
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| LET
15577
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| Nature's Way Products, Inc.
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| Vol #:
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| 137
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|
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| LET
15578
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| Nature's Way Products, Inc.
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| Vol #:
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| 137
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|
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| LET
15579
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| Nature's Way Products, Inc.
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| Vol #:
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| 137
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|
|
| LET
15580
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| Nature's Way Products, Inc.
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| Vol #:
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| 137
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|
|
| LET
15581
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| Nature's Way Products, Inc.
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| Vol #:
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| 137
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|
|
| LET
15582
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| Enzymatic Therapy
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| Vol #:
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| 137
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|
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| LET
15583
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| NBTY Inc.
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| Vol #:
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| 137
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| LET
15584
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| NBTY Inc.
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| Vol #:
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| 137
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| LET
15585
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| Lyons Health Products
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| Vol #:
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| 137
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|
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| LET
15586
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| Nature's Way Products, Inc.
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| Vol #:
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| 137
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|
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| LET
15587
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| Nature's Way Products, Inc.
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| Vol #:
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| 137
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|
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| LET
15588
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| Nature's Way Products, Inc.
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| Vol #:
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| 137
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|
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| LET
15589
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| SomaLabs, Inc.
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| Vol #:
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| 137
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|
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| LET
15590
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| Vita Pharmica, Inc.
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| Vol #:
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| 137
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|
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| LET
15591
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| Vita Pharmica, Inc.
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| Vol #:
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| 137
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|
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| LET
15592
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| Enzymatic Therapy
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| Vol #:
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| 137
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|
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| LET
15593
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| Metagenics. Inc.
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| Vol #:
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| 137
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|
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| LET
15594
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| NBTY Inc.
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| Vol #:
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| 137
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|
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| LET
15595
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| NBTY Inc.
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| Vol #:
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| 137
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|
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| LET
15596
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| Advocare International, L.P.
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| Vol #:
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| 137
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| LET
15597
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| NBTY Inc.
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| Vol #:
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| 137
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|
| | | | | | | | |
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| LET
15598
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| NBTY Inc.
|
| Vol #:
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| 137
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|
|
| LET
15599
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| NBTY Inc.
|
| Vol #:
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| 137
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|
|
| LET
15600
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| NBTY Inc.
|
| Vol #:
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| 137
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|
|
| LET
15601
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| NBTY Inc.
|
| Vol #:
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| 137
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|
|
| LET
15602
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| NBTY Inc.
|
| Vol #:
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| 137
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|
|
| LET
15603
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| NBTY Inc.
|
| Vol #:
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| 137
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|
|
| LET
15604
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| NBTY Inc.
|
| Vol #:
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| 137
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|
|
| LET
15605
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| NBTY Inc.
|
| Vol #:
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| 137
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|
|
| LET
15606
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| Nutronix International
|
| Vol #:
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| 137
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|
|
| 2003N-0528
|
| Revision of the Requirements for Spore-Forming Microorganisms
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|
|
| EC 2
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| My Self
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| Vol #:
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| 1
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|
|
| 2004N-0230
|
| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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|
|
| C 341
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| S and M McGalddery
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| Vol #:
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| 8
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|
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| C 342
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| R. Baxter
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| Vol #:
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| 8
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| C 343
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| D. Wallace, MD
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| Vol #:
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| 8
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| C 344
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| Dr. L. Cooper
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| Vol #:
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| 8
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|
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| C 345
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| K. Ebeling
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| Vol #:
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| 8
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|
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| C
346
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| Allergy and Asthma Specialist of Bloomfield Hills
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| Vol #:
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| 8
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|
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| C 347
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| J. Carter
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| Vol #:
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| 8
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|
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| C 348
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| D and A Driscoll
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| Vol #:
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| 8
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|
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| C 349
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| S. Dylan
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| Vol #:
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| 8
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| C 350
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| T. Anderson
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| Vol #:
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| 8
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|
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| C 351
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| C. McNutt
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| Vol #:
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| 8
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| C 352
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| D. Walls
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| Vol #:
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| 8
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| C 353
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| T. DeMann
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| Vol #:
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| 8
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|
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| C 354
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| E. Neville
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| Vol #:
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| 8
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| C 355
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| K. Bragg
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| Vol #:
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| 8
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| C 356
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| G. Evans
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| Vol #:
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| 8
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|
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| C 357
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| M. Medlock
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| Vol #:
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| 8
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| C 358
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| T. Kralj
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| Vol #:
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| 8
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|
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| C 359
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| A. Butcher
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| Vol #:
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| 8
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|
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| C 360
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| J. Hoover
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| Vol #:
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| 8
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| C 361
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| F. Crowley
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| Vol #:
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| 8
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| C 362
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| M. Pilewski
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| Vol #:
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| 8
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| C 363
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| K Willard and J Virant
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| Vol #:
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| 8
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| | | | | | | |
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| C 364
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| R. O'Leary, MD
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| Vol #:
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| 8
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| C 365
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| S. Rush
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| Vol #:
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| 8
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|
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| C 366
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| S. Leavitt
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| Vol #:
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| 8
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|
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| C 367
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| Mr and Mrs F and R Concilio
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| Vol #:
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| 8
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|
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| C 368
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| A. Rooney
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| Vol #:
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| 8
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|
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| C 369
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| R and C Fisher
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| Vol #:
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| 8
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| C 370
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| J. Rettagliata
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| Vol #:
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| 8
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|
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| C 371
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| N. Curley
|
| Vol #:
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| 8
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|
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| C 372
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| L. francoeur, Esq
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| Vol #:
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| 8
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|
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| C 373
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| D. Whitney
|
| Vol #:
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| 8
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|
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| C 374
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| L. Burnett
|
| Vol #:
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| 8
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|
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| C 375
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| B. Hjorth
|
| Vol #:
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| 8
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|
|
| C 376
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| D. Lombardo
|
| Vol #:
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| 8
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|
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| C 377
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| S. Cheney
|
| Vol #:
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| 8
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|
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| C 378
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| K. Munching
|
| Vol #:
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| 8
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|
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| C 379
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| J. Merkel
|
| Vol #:
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| 8
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|
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| C 380
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| P. Goswami
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| Vol #:
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| 8
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|
|
| C 381
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| G and R Powell
|
| Vol #:
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| 8
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|
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| C 382
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| Dr. A. Goswami
|
| Vol #:
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| 8
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|
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| C 383
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| K and D Berger
|
| Vol #:
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| 8
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|
|
| C 384
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| N. Metry, MD
|
| Vol #:
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| 8
|
|
|
| C 385
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| T. Medsker
|
| Vol #:
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| 8
|
|
|
| C 386
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| N. Barnes
|
| Vol #:
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| 8
|
|
|
| C 387
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| L. Fengstad
|
| Vol #:
|
| 8
|
|
|
| C 388
|
| H. Evers
|
| Vol #:
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| 8
|
|
|
| C 389
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| M. Newingham
|
| Vol #:
|
| 8
|
|
|
| C 390
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| T. Grenz
|
| Vol #:
|
| 8
|
|
|
| C 391
|
| E. Carlson
|
| Vol #:
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| 8
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|
|
| C 392
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| T. Antonino
|
| Vol #:
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| 8
|
|
|
| C 393
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| L. Johnson
|
| Vol #:
|
| 8
|
|
|
| C 394
|
| D. Newingham
|
| Vol #:
|
| 8
|
|
|
| C 395
|
| C and P Kent
|
| Vol #:
|
| 8
|
|
|
| C 396
|
| L and G Voss
|
| Vol #:
|
| 8
|
|
|
| C 397
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| A Peyser & B Abbott
|
| Vol #:
|
| 8
|
|
|
| C 398
|
| C. Bailey
|
| Vol #:
|
| 8
|
|
|
| C 399
|
| C. Cavanaugh
|
| Vol #:
|
| 8
|
|
|
| C 400
|
| J. Bazuzi
|
| Vol #:
|
| 8
|
|
| | | | | | | |
|
|
| C 401
|
| M. Bjork
|
| Vol #:
|
| 9
|
|
|
| C 402
|
| A. McSweeney, LPN
|
| Vol #:
|
| 9
|
|
|
| C 403
|
| C. Ramos
|
| Vol #:
|
| 9
|
|
|
| C 404
|
| M and A Folkins
|
| Vol #:
|
| 9
|
|
|
| C 405
|
| K. Merges
|
| Vol #:
|
| 9
|
|
|
| C 406
|
| E. Baron
|
| Vol #:
|
| 9
|
|
|
| C 407
|
| M. Duffy
|
| Vol #:
|
| 9
|
|
|
| C 408
|
| G. Flaskamp
|
| Vol #:
|
| 9
|
|
|
| C 409
|
| L. McTeigue
|
| Vol #:
|
| 9
|
|
|
| C 410
|
| D. Bloom
|
| Vol #:
|
| 9
|
|
|
| C 411
|
| S and C McKay
|
| Vol #:
|
| 9
|
|
|
| C 412
|
| M. Simmonds
|
| Vol #:
|
| 9
|
|
|
| C 413
|
| K. McGrury
|
| Vol #:
|
| 9
|
|
|
| C 414
|
| T. Selz
|
| Vol #:
|
| 9
|
|
|
| C 415
|
| J and J Dodson
|
| Vol #:
|
| 9
|
|
|
| C 416
|
| C. Timpte, PhD
|
| Vol #:
|
| 9
|
|
|
| C 417
|
| N and B Wickert
|
| Vol #:
|
| 9
|
|
|
| C 418
|
| L. Linthicum
|
| Vol #:
|
| 9
|
|
|
| C 419
|
| T and T Engleman
|
| Vol #:
|
| 9
|
|
|
| C 420
|
| T. Cruz
|
| Vol #:
|
| 9
|
|
|
| C 421
|
| J. McDonald
|
| Vol #:
|
| 9
|
|
|
| C 422
|
| D. Goelzer
|
| Vol #:
|
| 9
|
|
|
| C 423
|
| J and C Waters
|
| Vol #:
|
| 9
|
|
|
| C 424
|
| E. Zuckert
|
| Vol #:
|
| 9
|
|
|
| C 425
|
| C. Waters
|
| Vol #:
|
| 9
|
|
|
| C 426
|
| K. Doty, MD
|
| Vol #:
|
| 9
|
|
|
| C
427
|
| MMP Group
|
| Vol #:
|
| 9
|
|
|
| C 428
|
| S. Thomas
|
| Vol #:
|
| 9
|
|
|
| C 429
|
| K. Grace
|
| Vol #:
|
| 9
|
|
|
| C 430
|
| J . Brown
|
| Vol #:
|
| 9
|
|
|
| C 431
|
| R. Santos
|
| Vol #:
|
| 9
|
|
|
| C 432
|
| N. McGinnis
|
| Vol #:
|
| 9
|
|
|
| C 433
|
| J. Anderson
|
| Vol #:
|
| 9
|
|
|
| C 434
|
| R and B Vachha
|
| Vol #:
|
| 9
|
|
|
| C 435
|
| J. Wolfe
|
| Vol #:
|
| 9
|
|
|
| C 436
|
| J. Riehl
|
| Vol #:
|
| 9
|
|
|
| C 437
|
| S. Whittington
|
| Vol #:
|
| 9
|
|
| | | | | | | |
|
|
| C 438
|
| F. Holland
|
| Vol #:
|
| 9
|
|
|
| C 439
|
| K Willard & J Virant
|
| Vol #:
|
| 9
|
|
|
| C 440
|
| K. Gould
|
| Vol #:
|
| 9
|
|
|
| C 441
|
| J and R Rock
|
| Vol #:
|
| 9
|
|
|
| C 442
|
| S. Parker
|
| Vol #:
|
| 9
|
|
|
| C 443
|
| C. Filiato
|
| Vol #:
|
| 9
|
|
|
| C 444
|
| R. Cool
|
| Vol #:
|
| 9
|
|
|
| C
445
|
| Alvernon Allergy & Asthma, PC
|
| Vol #:
|
| 9
|
|
|
| C 446
|
| M. George
|
| Vol #:
|
| 9
|
|
|
| C 447
|
| D. Towarnicky
|
| Vol #:
|
| 9
|
|
|
| C 448
|
| C. Keathley
|
| Vol #:
|
| 9
|
|
|
| C 449
|
| D. Evans
|
| Vol #:
|
| 9
|
|
|
| C 450
|
| C. Pennacchio
|
| Vol #:
|
| 9
|
|
|
| C 451
|
| J. Nitchey
|
| Vol #:
|
| 9
|
|
|
| C 452
|
| M. Kaltwasser
|
| Vol #:
|
| 9
|
|
|
| C 453
|
| J. Bamberger,MS,RD,CD
|
| Vol #:
|
| 9
|
|
|
| C 454
|
| R. Goldman
|
| Vol #:
|
| 9
|
|
|
| C 455
|
| L and N Narry
|
| Vol #:
|
| 9
|
|
|
| C 456
|
| S. Burns
|
| Vol #:
|
| 9
|
|
|
| C 457
|
| A. Gunderson
|
| Vol #:
|
| 9
|
|
|
| C 458
|
| M and B Lopa
|
| Vol #:
|
| 9
|
|
|
| C 459
|
| D. Harrington
|
| Vol #:
|
| 9
|
|
|
| C 460
|
| A. Mudd
|
| Vol #:
|
| 9
|
|
|
| C 461
|
| J and S Thomas
|
| Vol #:
|
| 9
|
|
|
| C 462
|
| D and P Christie, RN/BS
|
| Vol #:
|
| 9
|
|
|
| C 463
|
| Dr. E. Shashoua
|
| Vol #:
|
| 9
|
|
|
| C 464
|
| N. Smith
|
| Vol #:
|
| 9
|
|
|
| C 465
|
| J and L Connolly
|
| Vol #:
|
| 9
|
|
|
| C 466
|
| C. Barnes
|
| Vol #:
|
| 9
|
|
|
| C 467
|
| A. Bonanno
|
| Vol #:
|
| 9
|
|
|
| C 468
|
| M. Beckman
|
| Vol #:
|
| 9
|
|
|
| C 469
|
| A. Rider
|
| Vol #:
|
| 9
|
|
|
| C 470
|
| L. Gold
|
| Vol #:
|
| 9
|
|
|
| C 471
|
| L. Mattson
|
| Vol #:
|
| 9
|
|
|
| C 472
|
| D. Holzman
|
| Vol #:
|
| 9
|
|
|
| C 473
|
| K. Gansemer
|
| Vol #:
|
| 9
|
|
|
| C 474
|
| J. Warfield
|
| Vol #:
|
| 9
|
|
| | | | | | | |
|
|
| C 475
|
| N. Lowerhouse
|
| Vol #:
|
| 9
|
|
|
| C 476
|
| E. Bonanno
|
| Vol #:
|
| 9
|
|
|
| C
477
|
| Manhasset Allergy and Asthma Associates, LLP
|
| Vol #:
|
| 9
|
|
|
| C
478
|
| Manhasset Allergy and Asthma Associates, LLP
|
| Vol #:
|
| 9
|
|
|
| C
479
|
| Manhasset Allergy and Asthma Associates, LLP
|
| Vol #:
|
| 9
|
|
|
| C 480
|
| A. Pask
|
| Vol #:
|
| 9
|
|
|
| C 481
|
| B and L Brookshire
|
| Vol #:
|
| 9
|
|
|
| C 482
|
| C. Cipolla
|
| Vol #:
|
| 9
|
|
|
| C 483
|
| K. Wilson
|
| Vol #:
|
| 9
|
|
|
| C 484
|
| S and D Burch
|
| Vol #:
|
| 9
|
|
|
| C 485
|
| A. Brown, D.O. and N. Brown, RN, BSN
|
| Vol #:
|
| 9
|
|
|
| C 486
|
| S and D Campbell
|
| Vol #:
|
| 9
|
|
|
| C 487
|
| T and Markman
|
| Vol #:
|
| 9
|
|
|
| C 488
|
| K. Pepper
|
| Vol #:
|
| 9
|
|
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| D. Ryan
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| Dr. M. Migliore
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| J. Migliore, PhD
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| Dr. P Jordan, MD
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| J. Mitchell
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| Arkansas Allergy & asthma Clinic, PA
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| G. Lafars
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| The Food Allergy & Anaphylaxis Network
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| J. Leonard
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| J. Morgan
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| H. Cornwell
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537
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| Mount Sinai School of Medicine
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| 10
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| K. Catacutan
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| 10
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| Mr and Mrs C Hucek
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| Sourthern California Permanente Medical group
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| A. Gordon
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| W. Mileski
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| S. Pereira
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| K. Scheer
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| S. Machtinger, MD
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| L. Harty
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| 10
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| T. Bizokas
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| 10
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| H. Yantus
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| R and A Muradaz
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| V. Weikers
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| S. Zachos
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| W. Green
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| J. Pace
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| J. DeMann
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| D. Ford
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| K. and M O'Mara
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| C. Vaughan
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| R. Rosebrock
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| 10
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| E. Hoehn
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| D. D'Antuono
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| W. Markle
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| 10
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| D and J King
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| 10
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| R and J Muradaz
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| 10
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| D. Bugg
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| Vol #:
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| 10
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| L. Colasacco
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| Vol #:
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| 10
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| P. Kaier
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| 10
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| K. Green
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| Vol #:
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| 10
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| C 587
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| M. Green
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| 10
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| D. Green
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| 10
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| C 589
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| S. Shaker
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| Vol #:
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| 10
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| C 590
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| C. Mitson
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| Vol #:
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| 10
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| C 591
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| A. Pickrel
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| Vol #:
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| 10
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| C 592
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| L. Cuppett
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| 10
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| B Paulson and S Reed
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| C 594
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| L and C Wundrow
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| Vol #:
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| 10
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| S and J Wundrow
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| Vol #:
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| 10
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| C 596
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| J and E Duellman
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| 10
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| E. Fliss
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| 10
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| C 598
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| D. Tank
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| Vol #:
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| 10
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| C 599
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| D. Terrien
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| 10
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| C 600
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| W and E Muller
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| Vol #:
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| 10
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| D. Muller and S Forbes
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| Vol #:
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| 11
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| C 602
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| K. Morgan
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| 11
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| R. Wang,RN,MPH
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| 11
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| T. Leibowitz
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| 11
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| M and A Muradaz
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| N. Proteau
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| G and J Schmeling
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| 11
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| M. Megroz
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| 11
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| D. Markley
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| 11
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| C 610
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| T. Kish
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| Vol #:
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| 11
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| D. Nelson
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| Vol #:
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| 11
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| T. Moore
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| Vol #:
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| 11
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| C 613
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| L. Bischoff
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| Vol #:
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| 11
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| C 614
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| L. Peterson
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| Vol #:
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| 11
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| C 615
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| M. Hornickle
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| 11
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| B and N Wickert
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| 11
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| D. Kresock
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| 11
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| N. Kresock
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| 11
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| S and S Brickman
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| Vol #:
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| D. Gianfrancesco
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| 11
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| M. Reff
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| J. Farhat
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| J. Jordan
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| D. McCook
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| T. Notarcola
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| M. Gruebele
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| M. Villa
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| 11
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| G. Spezia
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| 11
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| R. Waggoner
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| 11
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| D. Rosenzweig
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| 11
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| S. Ruple
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| 11
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| A. Vannoy
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| Vol #:
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| S. Gale
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| D Weiner and J McLaughlin
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| S. Curiale
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| 11
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| E and A Karlin
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| 11
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| C 637
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| L. Collins
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| Vol #:
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| 11
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| C 638
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| M. Migliore
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| Vol #:
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| 11
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| C 639
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| W. Tichenor, MD
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| Vol #:
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| 11
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| C 640
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| T. Alburger
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| Vol #:
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| 11
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| C 641
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| A. Streitz
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| Vol #:
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| 11
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| C 642
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| Form Letter
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| Vol #:
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| 12
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|
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| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
|
|
|
| LET
7
|
| HFS-800 to Solae LLC
|
| Vol #:
|
| 5
|
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
|
|
| EC
6
|
| Minneapolis VAMC Institutional Review Board
|
| Vol #:
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| 2
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|
|