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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 K944834
Device Name UNSCENTED MENSTRUAL TAMPONS
Applicant
TAMBRANDS, INC.
777 WESTCHESTER AVE.
WHITE PLAINS,  NY  10604
Applicant Contact JEROME B WAINICK
Correspondent
TAMBRANDS, INC.
777 WESTCHESTER AVE.
WHITE PLAINS,  NY  10604
Correspondent Contact JEROME B WAINICK
Regulation Number884.5470
Classification Product Code
HEB  
Date Received09/30/1994
Decision Date 12/21/1994
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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