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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 K131543
Device Name TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
Applicant
PROCTER & GAMBLE CO.
6110 CENTER HILL AVE.
CINCINNATI,  OH  45224
Applicant Contact KATHLEEN BLIESZNER
Correspondent
PROCTER & GAMBLE CO.
6110 CENTER HILL AVE.
CINCINNATI,  OH  45224
Correspondent Contact KATHLEEN BLIESZNER
Regulation Number884.5470
Classification Product Code
HEB  
Date Received05/29/2013
Decision Date 06/20/2013
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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