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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 K860598
Device Name MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS
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 Received02/19/1986
Decision Date 03/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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