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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 K040999
Device Name TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
Applicant
PROCTER & GAMBLE CO.
6110 CENTER HILL AVE.
CINCINNATI,  OH  45224
Applicant Contact MARK M ANDERSON
Correspondent
PROCTER & GAMBLE CO.
6110 CENTER HILL AVE.
CINCINNATI,  OH  45224
Correspondent Contact MARK M ANDERSON
Regulation Number884.5470
Classification Product Code
HEB  
Date Received04/19/2004
Decision Date 07/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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