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| Dockets Entered December
3, 2004
Table of Contents
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| Docket #
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| Title
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| 1994P-0268
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| Essential Use Exemption for
Implantable Infusion Pump
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| 1997S-0162
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| 30-Day Structure Function Claim
Notification Letters Dietary
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| 2003D-0383
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| Draft Guidance for Industry
and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro
Diagnostic Devices Intended for Professional Use; Availability
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| 2004D-0440
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| Guidance for Industry on Computerized
Systems Used in Clinical Trials
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| 2004D-0443
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| Guidance for Industry on Quality
Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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| 2004F-0455
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| Filing of Food Additive Petition
(FAP 3M4744)
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| 2004N-0063
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| Agency Information Collection
Activities; Proposed Collection; Comment Request; Voluntary Registration
of Cosmetic Product Establishments
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| 2004N-0217
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| Nutrient content claims: DHA,
EPA, and ALA (Omega-3 Fatty Acids)
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| 2004N-0330
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| Suicidality in Clinical Trials
for Antidepressant Drugs in Pediatric Patients
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| 2004N-0346
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| Over-the-Counter Drug Products;
Safety and Efficacy Review; Additional Antidiarrheal Ingredient
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| 2004N-0432
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| Radioactive Drugs for Certain
Research Uses; Public Meeting
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| 2004N-0498
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| Agency Information Collection
Activities; Proposed Collection; Comment Request; Medical Devices;
Device Tracking
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| 2004P-0276
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| Initiate proceedings to permit
Computerized Thermal Imaging, Inc. (CTI) to supplement the administrative
record in connection with CTI's premarket approval application in
P010035
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| 2004P-0411
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| Compel Enforcement and Regulation
of Amyl Nitrate
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| 2004V-0536
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| Laser Light Show
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| 1994P-0268
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| Essential Use Exemption for
Implantable Infusion Pump
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| PDN
1
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| HFZ 1 to Medtronic MiniMed
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| Vol #:
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| 1
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| 1997S-0162
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| 30-Day Structure Function
Claim Notification Letters Dietary
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| LET
14922
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| Enzymatic Therapy
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| Vol #:
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| 132
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| LET
14923
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| Enzymatic Therapy
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| Vol #:
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| 132
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| LET
14924
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| Enzymatic Therapy
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| Vol #:
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| 132
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| LET
14925
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14926
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14927
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14928
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14929
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14930
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14931
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14932
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14933
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14934
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14935
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14936
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14937
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14938
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14939
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14940
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| Leiner Health Products
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| Vol #:
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| 132
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| 2003D-0383
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| Draft Guidance for Industry
and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro
Diagnostic Devices Intended for Professional Use; Availability
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| GDL
2
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| Guidance
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2004D-0440
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| Guidance for Industry on
Computerized Systems Used in Clinical Trials
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| C
2
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| International Assn for Phamaceutical
Science and Technology (PDA)
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| Vol #:
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| 1
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| 2004D-0443
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| Guidance for Industry on
Quality Systems Approach to Pharmaceutical Current Good Manufacturing
Regulations
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| C
5
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| Aventis Pasteur, Inc.
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| Vol #:
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| 1
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| C
6
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| International Assn for Pharmaceutical
Science and Technology (PDA)
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| Vol #:
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| 1
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| EXT
5
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| Linde Gas, LLC
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| Vol #:
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| 1
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| 2004F-0455
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| Filing of Food Additive Petition
(FAP 3M4744)
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|
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2004N-0063
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| Agency Information Collection
Activities; Proposed Collection; Comment Request; Voluntary Registration
of Cosmetic Product Establishments
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2004N-0217
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| Nutrient content claims:
DHA, EPA, and ALA (Omega-3 Fatty Acids)
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|
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| C
2
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| Consumer Federation of America
(CFA)
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| Vol #:
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| 3
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| 2004N-0330
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| Suicidality in Clinical Trials
for Antidepressant Drugs in Pediatric Patients
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| C 5
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| C. Tueller
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| Vol #:
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| 3
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| 2004N-0346
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| Over-the-Counter Drug Products;
Safety and Efficacy Review; Additional Antidiarrheal Ingredient
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| C
1
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| PAREXEL International
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| Vol #:
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| 2
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| 2004N-0432
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| Radioactive Drugs for Certain
Research Uses; Public Meeting
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|
| | | | | | | | |
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| |
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| EXT
1
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| American College of nuclear Physicians (ACNP)
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| Vol #:
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| 1
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| EXT
2
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| Society of Nuclear Medicine (SNM)
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| Vol #:
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| 1
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| |
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| 2004N-0498
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking
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|
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| N
1
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| FDA
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| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0276
|
| Initiate proceedings to permit Computerized Thermal Imaging, Inc. (CTI) to supplement the administrative record in connection with CTI's premarket approval application in P010035
|
|
|
|
|
|
|
|
|
|
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| LET
2
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| Computerized Thermal Imaging, Inc.
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| Vol #:
|
| 2
|
|
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|
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| 2004P-0411
|
| Compel Enforcement and Regulation of Amyl Nitrate
|
|
|
|
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| SUP
3
References
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| Committee to Monitor Poppers
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| Vol #:
|
| 4
|
|
| |
|
| 2004V-0536
|
| Laser Light Show
|
|
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| VAR
1
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| Forum Developers Limited Partnership
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| Vol #:
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| 1
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|
