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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Garment, Protective, For Incontinence
510(k) Number K861863
Device Name MODIFIED PROTECTIVE GARMENT
Applicant
Procter & Gamble Mfg. Co.
P.O. Box 599
Cincinnati,  OH  45201
Applicant Contact JAMES T O'REILLY
Correspondent
Procter & Gamble Mfg. Co.
P.O. Box 599
Cincinnati,  OH  45201
Correspondent Contact JAMES T O'REILLY
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received05/15/1986
Decision Date 08/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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