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Dockets Management
Dockets Entered On July 26, 2005
Table of Contents
Docket # Title
1994N-0418 Order for Certain Class III Devices, including S&E info
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
1997N-0484T Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1997V-0231 Laser light show
1998V-1269 Laser Light Show
1999V-5521 Laser Light Show, SpectraScan LitePipe LP2-X Mobolazer
2004P-0464 Vitamin D and Calcium and Reduced Risk of Osteoporosis
2005D-0169 Guidance on Useful Written Consumer Medication Information (CMI)
2005N-0100 Agency Information Collection Activities; Proposed Collection; Comment Request; CGMP Regulations for Finished Pharmaceuticals
2005P-0291 ANDA or Section 505(b)(2),for inhalation drug products containing a combination of active ingredients albuterol sulfate and ipratropium hydrochloride
2005P-0292 513(e) Reclassification Petition for Lamicel Osmotic Cervical Dilator
2005P-0293 Citizen Petition Regarding the Labeling of Vitamin A by Supplement Companies
2005P-0295 Standard Identity for Pure Birch Syrup and Birch Breakdast Style Syrup
2005V-0281 Laser Light Show
2005V-0294 Laser Light Show
1994N-0418 Order for Certain Class III Devices, including S&E info
LET 1 HFZ-400 to Philips Medical Systems Vol #: 23
LET 2 HFZ-400 to Medtronic Physio-Control Corp. Vol #: 23
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
RPT 279 Herbal Cure USA LLC Vol #: 214
RPT 280 Chrysantis/Ball Horticultural Company Vol #: 217
RPT 281 Rainforest Botanicals LLC Vol #: 218
1997N-0484T Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
C 1 The Sperm & Embryo Bank of New Jersey, Inc. et al. Vol #: 1
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 16349 The Daily Wellness Company Vol #: 146
LET 16350 USA CTT Co., Inc. Vol #: 146
LET 16351 MRF Worldwide, LLC Vol #: 146
LET 16352 Rejuvenation Science Vol #: 146
LET 16353 Rejuvenation Science Vol #: 146
LET 16354 Rejuvenation Science Vol #: 146
LET 16355 Rejuvenation Science Vol #: 146
LET 16356 Rejuvenation Science Vol #: 146
LET 16357 Rejuvenation Science Vol #: 146
LET 16358 Rejuvenation Science Vol #: 146
LET 16359 Rejuventation Science Vol #: 146
LET 16360 Rejuvenation Science Vol #: 146
LET 16361 Rejuvenation Science Vol #: 146
LET 16362 Rejuvenation Science Vol #: 146
LET 16363 New Chapter, Inc. Vol #: 146
LET 16364 New Chapter, Inc. Vol #: 146
LET 16365 New Chapter, Inc. Vol #: 146
LET 16366 New Chapter, Inc. Vol #: 146
LET 16367 New Chapter, Inc. Vol #: 146
LET 16368 New Chapter, Inc. Vol #: 146
LET 16369 New Chapter, Inc. Vol #: 146
LET 16370 New Chapter, Inc. Vol #: 146
LET 16371 New Chapter, Inc. Vol #: 146
1997V-0231 Laser light show
VRA 5 HFZ-200 to Paramount Event Services, Inc. dba Paramount Event Services, Inc. Vol #: 1
1998V-1269 Laser Light Show
VRA 3 HFZ-200 to Wild Adventures Valdosta, LLC Vol #: 1
1999V-5521 Laser Light Show, SpectraScan LitePipe LP2-X Mobolazer
VRA 2 HFZ-200 to Pyro Magic, Inc. DBA Laser Pyro Shows Vol #: 1
2004P-0464 Vitamin D and Calcium and Reduced Risk of Osteoporosis
LET 3 Beverage Institute for Health and Wellness (BHWI) Vol #: 9
2005D-0169 Guidance on Useful Written Consumer Medication Information (CMI)
C 6 Public Citizen Vol #: 1
2005N-0100 Agency Information Collection Activities; Proposed Collection; Comment Request; CGMP Regulations for Finished Pharmaceuticals
N 2 FDA Vol #: 1
2005P-0291 ANDA or Section 505(b)(2),for inhalation drug products containing a combination of active ingredients albuterol sulfate and ipratropium hydrochloride
CP 1 Frommer Lawrence and Haug LLP Vol #: 1
2005P-0292 513(e) Reclassification Petition for Lamicel Osmotic Cervical Dilator
ACK 1 HFA-305 to Medtronic Xomed Vol #: 1
CCP 1 Medtronic Xomed Vol #: 1
2005P-0293 Citizen Petition Regarding the Labeling of Vitamin A by Supplement Companies
ACK 1 HFA-305 to D. J. Getoff Vol #: 1
CP 1 D. J. Getoff Vol #: 1
2005P-0295 Standard Identity for Pure Birch Syrup and Birch Breakdast Style Syrup
ACK 1 HFA-305 to Alaska Birch Syrupmakers Association Vol #: 1
CP 1 Alaska Birch Syrupmakers Association Vol #: 1
2005V-0281 Laser Light Show
VRA 1 HFZ-200 to C/J Media dba InterVision Vol #: 1
2005V-0294 Laser Light Show
ACK 1 HFA-305 to Demilune Digital Designs Vol #: 1
VAR 1 Demilune Digital Designs Vol #: 1

Page created on August 5, 2005 kk

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