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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 K002096
Device Name TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR
Applicant
PROCTER & GAMBLE CO.
6100 CENTER HILL AVE.
CINCINNATI,  OH  45224
Applicant Contact MARK M ANDERSON
Correspondent
PROCTER & GAMBLE CO.
6100 CENTER HILL AVE.
CINCINNATI,  OH  45224
Correspondent Contact MARK M ANDERSON
Regulation Number884.5470
Classification Product Code
HEB  
Date Received07/11/2000
Decision Date 09/08/2000
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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