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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, Scented-Deodorized
510(k) Number K081555
Device Name TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
Applicant
Procter & Gamble Co.
6110 Center Hill Ave.
Cincinnati,  OH  45224
Applicant Contact LENORE FAULHABER
Correspondent
Procter & Gamble Co.
6110 Center Hill Ave.
Cincinnati,  OH  45224
Correspondent Contact LENORE FAULHABER
Regulation Number884.5460
Classification Product Code
HIL  
Subsequent Product Code
HEB  
Date Received06/03/2008
Decision Date 06/27/2008
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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