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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pessary, Vaginal
510(k) Number K151413
Device Name Always/Tampax bladder supports
Applicant
Procter & Gamble
6110 Center Hill Ave.
Cincinnati,  OH  45224
Applicant Contact LENORE FAULHABER
Correspondent
Procter & Gamble
6110 Center Hill Ave.
Cincinnati,  OH  45224
Correspondent Contact LENORE FAULHABER
Regulation Number884.3575
Classification Product Code
HHW  
Date Received05/27/2015
Decision Date 12/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT01762345
NCT02131311
NCT02160314
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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