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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, scented, deodorized
510(k) Number K032173
Device Name FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
Applicant
FIRST QUALITY HYGIENIC, INC.
73 FRANKLIN TURNPIKE
ALLENDALE,  NJ  07401
Applicant Contact ROBERT J STAAB
Correspondent
FIRST QUALITY HYGIENIC, INC.
73 FRANKLIN TURNPIKE
ALLENDALE,  NJ  07401
Correspondent Contact ROBERT J STAAB
Regulation Number884.5460
Classification Product Code
HIL  
Date Received07/16/2003
Decision Date 09/03/2003
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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