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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tampon, menstrual, unscented
510(k) Number K963034
Device Name FEMTEX GENTLE TOUCH TAMPONS
Applicant
FIRST QUALITY HYGIENIC, INC.
73 FRANKLIN TURNPIKE
ALLENDALE,  NJ  07401
Applicant Contact ROBERT J STAAB, PH.D.
Correspondent
FIRST QUALITY HYGIENIC, INC.
73 FRANKLIN TURNPIKE
ALLENDALE,  NJ  07401
Correspondent Contact ROBERT J STAAB, PH.D.
Regulation Number884.5470
Classification Product Code
HEB  
Date Received08/05/1996
Decision Date 11/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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