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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 K853079
Device Name PROTECTIVE PAD FOR INCONTINENCE
Applicant
I.C.D. INDUSTRIES, INC.
630 CLARK AVE.
KING OF PRUSSIA,  PA  19406
Applicant Contact HUGH ROBISON
Correspondent
I.C.D. INDUSTRIES, INC.
630 CLARK AVE.
KING OF PRUSSIA,  PA  19406
Correspondent Contact HUGH ROBISON
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received07/23/1985
Decision Date 08/09/1985
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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