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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 K920238
Device Name PRIVATE LABELS AND FEMTEX
Applicant
FIRST QUALITY HYGIENIC, INC.
73 FRANKLIN TURNPIKE
ALLENDALE,  NJ  07401
Applicant Contact ROBERT STAAB
Correspondent
FIRST QUALITY HYGIENIC, INC.
73 FRANKLIN TURNPIKE
ALLENDALE,  NJ  07401
Correspondent Contact ROBERT STAAB
Regulation Number884.5470
Classification Product Code
HEB  
Date Received01/17/1992
Decision Date 08/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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