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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 K061486
Device Name TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)
Applicant
Procter & Gamble Co.
2001 Pennsylvania Ave.
Suite 575
Washington,  DC  20006
Applicant Contact PHILIP J PHILLIPS
Correspondent
Procter & Gamble Co.
2001 Pennsylvania Ave.
Suite 575
Washington,  DC  20006
Correspondent Contact PHILIP J PHILLIPS
Regulation Number884.5470
Classification Product Code
HEB  
Date Received05/31/2006
Decision Date 08/01/2006
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
Predetermined Change
Control Plan Authorized		 No
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