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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 K113699
Device Name TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED
Applicant
THE PROCTER & GAMBLE COMPANY
6110 CANTER HILL AVENUE
CINCINNATI,  OH  45224
Applicant Contact KATHLEEN BLIESZNER
Correspondent
THE PROCTER & GAMBLE COMPANY
6110 CANTER HILL AVENUE
CINCINNATI,  OH  45224
Correspondent Contact KATHLEEN BLIESZNER
Regulation Number884.5470
Classification Product Code
HEB  
Date Received12/16/2011
Decision Date 01/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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