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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Menstrual, Unscented
510(k) Number K003843
Device Name ENVIVE MINIFORMS
Applicant
Procter & Gamble Co.
6110 Center Hill Ave.
Cincinnati,  OH  45224
Applicant Contact KATHLEEN C BLIEZNER
Correspondent
Procter & Gamble Co.
6110 Center Hill Ave.
Cincinnati,  OH  45224
Correspondent Contact KATHLEEN C BLIEZNER
Regulation Number884.5435
Classification Product Code
HHD  
Date Received12/12/2000
Decision Date 02/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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