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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 K952344
Device Name SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS
Applicant
TAMBRANDS, INC.
777 WESTCHESTER AVE.
WHITE PLAINS,  NY  10604
Applicant Contact JEROME B EAINICK
Correspondent
TAMBRANDS, INC.
777 WESTCHESTER AVE.
WHITE PLAINS,  NY  10604
Correspondent Contact JEROME B EAINICK
Regulation Number884.5460
Classification Product Code
HIL  
Date Received05/19/1995
Decision Date 07/28/1995
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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