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| Dockets Entered
On June 25, 2004
Table of Contents
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| Docket #
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| Title
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| |
|
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| 2003N-0456
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| Agency Information Collection:Prevention of Medical Gas Mix-ups at Health Care Facilities
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| |
|
|
| 2003N-0468
|
| Medical Devices; Effective Date of Requirement for Premarket
|
| |
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| 2004M-0012
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| P030002, crystalens Model AT-45 Accommodating Posterior Chamber Intraocular Lens (IOL),
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| |
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| 2004M-0022
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| P010059 - Morcher Capsular Tension Ring, Types 14, 14A and 14C, Approved 10/23/03
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| |
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|
| 2004M-0024
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| P970020/S040 - ACS MULTI-LINK RX DUET, ACS MULTI-LINK OTW DUET, ACS MULTI-LINK RX TRISTAR, ACS MULTI-LINK OTW TRISTAR, ACS MULTI-LINK RX ULTRA, ACS MULTI-LINK OTW ULTRA, ACS MULTI-LINK RX TETRA, ACS M
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|
|
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|
|
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|
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| 2004M-0031
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| PMA P020031, Microsulis Microwave Endometrial Ablation (MEA) System
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| |
|
|
| 2004M-0064
|
| P030005 - CONTAK RENEWAL TR Models H125 and H120 with the Model 2865 Version 1.8 Application Software
|
| |
|
|
| 2004M-0084
|
| HDE Number: H030004; Applicant: Menssana Research Inc.; Device Tradename: Heartsbreath
|
| |
|
|
| 2004M-0090
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| H030003, DeBakey VAD Child Left Ventricular Assist System
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| |
|
|
| 2004M-0116
|
| P030006 - Prolieve Thermodilatation System
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| |
|
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| 2004M-0134
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| Refractec, Inc.; PMA Approval of ViewPoint TM CK R System, P010018/S005
|
| |
|
|
| 2004M-0145
|
| P020006 - Enteryx Procedure Kit, Approved 4/22/03
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| |
|
|
| 2004M-0147
|
| P890064/S009 - Digene Hybrid Capture 2 (HC2) High-Risk HPV DNA Test
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| |
|
|
| 2004N-0194
|
| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
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| |
|
|
| 2004N-0226
|
| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| |
|
|
| 2004P-0271
|
| Determine that Drying Lotion, a Topical Acne Drug Products for Over the Counter Human Use in 21 CFR 333 Subpart D can contain in combination both Sulfur (10.0%) and Salicylic Acid (2.0%) as the active
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|
|
|
|
|
|
|
|
| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
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| |
|
|
| 1998N-0359
|
| Program priorities/Center for Food Safety & Applied Nutritin
|
|
|
| N
6
|
| FDA
|
| Vol #:
|
| 8
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| EMC 7300
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| L. Dator
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| Vol #:
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| 279
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| |
|
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| EMC 7301
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| no name
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| Vol #:
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| 279
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| |
|
|
| EMC 7302
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| no name
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| Vol #:
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| 279
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| |
|
|
| EMC 7303
|
| E. Smith
|
| Vol #:
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| 279
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| EMC 7304
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| R. S. Tannenbaum
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| Vol #:
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| 279
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|
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| EMC 7305
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| K. McKenna
|
| Vol #:
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| 279
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| EMC 7306
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| F. M. Thalacker
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| Vol #:
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| 279
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| |
|
|
| EMC 7307
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| M. McMartin
|
| Vol #:
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| 279
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| |
|
|
| EMC 7308
|
| M. Sheehan
|
| Vol #:
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| 279
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| |
|
|
| EMC 7309
|
| Lisa Parsley, RN MSN
|
| Vol #:
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| 279
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| |
|
|
| EMC 7310
|
| S. Landers
|
| Vol #:
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| 279
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| EMC 7311
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| D. Jackson
|
| Vol #:
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| 279
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| EMC 7312
|
| L. Huddleston
|
| Vol #:
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| 279
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| EMC 7313
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| M. Bagnal
|
| Vol #:
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| 279
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| |
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|
| EMC 7314
|
| N. Petrow
|
| Vol #:
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| 279
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| EMC 7315
|
| J. Tierney
|
| Vol #:
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| 279
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| |
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| EMC 7316
|
| Blanca
|
| Vol #:
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| 279
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| |
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| EMC 7317
|
| I. Nossel
|
| Vol #:
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| 279
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| |
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| EMC 7318
|
| I. Nossel
|
| Vol #:
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| 279
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| EMC 7319
|
| V. Kallianes
|
| Vol #:
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| 279
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| |
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| EMC 7320
|
| E. Rodacker
|
| Vol #:
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| 279
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| |
|
|
| EMC 7321
|
| D. Gary
|
| Vol #:
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| 279
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| EMC 7322
|
| M. Przygoda
|
| Vol #:
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| 279
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| |
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| EMC 7323
|
| R. Johnson
|
| Vol #:
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| 279
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| |
|
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| EMC 7324
|
| N. Puffett
|
| Vol #:
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| 279
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| |
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|
| EMC 7325
|
| K. McVicker
|
| Vol #:
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| 279
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| |
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| EMC 7326
|
| K. Kesler
|
| Vol #:
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| 279
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| |
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| EMC 7327
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| C. Gallopin
|
| Vol #:
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| 279
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| EMC 7328
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| A. Riley
|
| Vol #:
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| 279
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| EMC 7329
|
| S. White
|
| Vol #:
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| 279
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| |
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| EMC 7330
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| R. Clary
|
| Vol #:
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| 279
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| EMC 7331
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| L. Howe
|
| Vol #:
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| 279
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| |
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| EMC 7332
|
| S. Smith
|
| Vol #:
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| 279
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| |
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| EMC 7333
|
| C. Siverson
|
| Vol #:
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| 279
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| EMC 7334
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| K. Weigle
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| Vol #:
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| 279
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| EMC 7335
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| L. Christiansen
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| Vol #:
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| 279
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| EMC 7336
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| A. Meza
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| Vol #:
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| 279
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| |
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| EMC 7337
|
| J. A. Bylander
|
| Vol #:
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| 279
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| |
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| EMC 7338
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| R. Wayne
|
| Vol #:
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| 279
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| EMC 7339
|
| J. M. Mack, P.E.
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| Vol #:
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| 279
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| |
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| EMC 7340
|
| L. Frankel
|
| Vol #:
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| 279
|
| |
|
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| EMC 7341
|
| K. Wujcik
|
| Vol #:
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| 279
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| |
|
|
| EMC 7342
|
| M. Boyle
|
| Vol #:
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| 279
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| |
|
|
| EMC 7343
|
| R. Olson
|
| Vol #:
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| 279
|
| |
|
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| EMC 7344
|
| P. D. Simmons PH.D.
|
| Vol #:
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| 279
|
| |
|
|
| EMC 7345
|
| J. Miles
|
| Vol #:
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| 279
|
| |
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|
| EMC 7346
|
| S. Kugelmass
|
| Vol #:
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| 279
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| |
|
|
| EMC 7347
|
| H. Yee
|
| Vol #:
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| 279
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| |
|
|
| EMC 7348
|
| C. M. Barber
|
| Vol #:
|
| 279
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|
| | | | | | | |
| |
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| EMC 7349
|
| S. Siegfriedt
|
| Vol #:
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| 279
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| |
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|
| EMC 7350
|
| L. McPherson
|
| Vol #:
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| 279
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| EMC 7351
|
| L. Schurmann
|
| Vol #:
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| 279
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| |
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| EMC 7352
|
| M. Matzkin
|
| Vol #:
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| 279
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| |
|
|
| EMC 7353
|
| Rev. G. McFarland
|
| Vol #:
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| 279
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| |
|
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| EMC 7354
|
| K. Franklin
|
| Vol #:
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| 279
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| |
|
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| EMC 7355
|
| E. G. Reardon
|
| Vol #:
|
| 279
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| |
|
|
| EMC 7356
|
| E. Koskan
|
| Vol #:
|
| 279
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| |
|
|
| EMC 7357
|
| K. Troyan
|
| Vol #:
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| 279
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| |
|
|
| EMC 7358
|
| S. Rose
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7359
|
| K. Koch
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7360
|
| M. Monroe
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7361
|
| S. Goodall
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7362
|
| S. Goodall
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7363
|
| C. Mcneilly
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7364
|
| K. Attfield
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7365
|
| P. Mackey
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7366
|
| Amelia Blakeman
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7367
|
| J. Strathy
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7368
|
| J. Reise
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7369
|
| T. Hester
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7370
|
| J. Warren-findlow
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7371
|
| C. Christiansen
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7372
|
| K. Smith
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7373
|
| J. Bowie
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7374
|
| Z. Brown
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7375
|
| J. Gaddis
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7376
|
| M. Crissman
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7377
|
| P. Hornsey
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7378
|
| T. Norelli
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7379
|
| N. Pechenik
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7380
|
| D. Evans
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7381
|
| E. Armm
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7382
|
| J. Reynolds
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7383
|
| L. Reinhart
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7384
|
| P. J. Shulman
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7385
|
| J. Krinsky-Rubber
|
| Vol #:
|
| 279
|
|
| | | | | | | | |
| |
|
|
| EMC 7386
|
| J. Forlani
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7387
|
| T. Swan
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7388
|
| K. Miller
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7389
|
| N. Myhre
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7390
|
| M. Jackson
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7391
|
| M. Prosser
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7392
|
| P. Futerer
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7393
|
| M. Pohlman
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7394
|
| K. Wamsley
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7395
|
| L. Smith
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7396
|
| J. Moless
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7397
|
| M. Salt
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7398
|
| J. Fox
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7399
|
| M. Fleming
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7400
|
| L. D. Berkowitz
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7401
|
| L. Goldfine
|
| Vol #:
|
| 279
|
| |
|
|
| EMC 7402
|
| A. E. Johnsrud
|
| Vol #:
|
| 279
|
| |
|
|
| 2003N-0456
|
| Agency Information Collection:Prevention of Medical Gas Mix-ups at Health Care Facilities
|
| |
|
|
| N
3
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0468
|
| Medical Devices; Effective Date of Requirement for Premarket
|
| |
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004M-0012
|
| P030002, crystalens Model AT-45 Accommodating Posterior Chamber Intraocular Lens (IOL),
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004M-0022
|
| P010059 - Morcher Capsular Tension Ring, Types 14, 14A and 14C, Approved 10/23/03
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004M-0024
|
| P970020/S040 - ACS MULTI-LINK RX DUET, ACS MULTI-LINK OTW DUET, ACS MULTI-LINK RX TRISTAR, ACS MULTI-LINK OTW TRISTAR, ACS MULTI-LINK RX ULTRA, ACS MULTI-LINK OTW ULTRA, ACS MULTI-LINK RX TETRA, ACS M
|
|
|
|
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004M-0031
|
| PMA P020031, Microsulis Microwave Endometrial Ablation (MEA) System
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004M-0064
|
| P030005 - CONTAK RENEWAL TR Models H125 and H120 with the Model 2865 Version 1.8 Application Software
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| 2004M-0084
|
| HDE Number: H030004; Applicant: Menssana Research Inc.; Device Tradename: Heartsbreath
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004M-0090
|
| H030003, DeBakey VAD Child Left Ventricular Assist System
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004M-0116
|
| P030006 - Prolieve Thermodilatation System
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004M-0134
|
| Refractec, Inc.; PMA Approval of ViewPoint TM CK R System, P010018/S005
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004M-0145
|
| P020006 - Enteryx Procedure Kit, Approved 4/22/03
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004M-0147
|
| P890064/S009 - Digene Hybrid Capture 2 (HC2) High-Risk HPV DNA Test
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0194
|
| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
|
| |
|
|
| NEC
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0226
|
| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0271
|
| Determine that Drying Lotion, a Topical Acne Drug Products for Over the Counter Human Use in 21 CFR 333 Subpart D can contain in combination both Sulfur (10.0%) and Salicylic Acid (2.0%) as the active
|
|
|
|
|
|
|
|
|
| CP
1
Tab 1, 2,
3, 4
|
| D'ARCY Revolutionary Skincare
|
| Vol #:
|
| 1
|
| |
|
|
| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
|
| |
|
|
| C
1
|
| Vance's Manufacturing Inc
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 3
|
| Mr & Mrs Gerald and Deanna Hernesmaa
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 4
|
| Mr & Mrs Gerald and Deanna Hernesmaa
|
| Vol #:
|
| 4
|
| |
|
|
| EMC
5
|
| Fundacion LACMAT IBFAN Argentina
|
| Vol #:
|
| 4
|
| |
|
|
| EMC
6
|
| Relive International Inc
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
7
|
| American Soybean Association
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
8
|
| The Solae Company
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
9
|
| Weston A Price Foundation
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
10
|
| United Soybean Board
|
| Vol #:
|
| 5
|
|
|
