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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 K971228
Device Name FEMTEX 100% COTTON TAMPONS
Applicant
REGU-TECH ASSOC., INC.
73 FRANKLIN TPK.
ALLENDALE,  NJ  07401
Applicant Contact ROBERT J STAAB
Correspondent
REGU-TECH ASSOC., INC.
73 FRANKLIN TPK.
ALLENDALE,  NJ  07401
Correspondent Contact ROBERT J STAAB
Regulation Number884.5470
Classification Product Code
HEB  
Date Received01/21/1997
Decision Date 04/09/1997
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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