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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Ostomy
510(k) Number K844046
Device Name UNITED SKIN BARRIERS
Applicant
HOWMEDICA CORP.
235 EAST 42ND ST.
NEW YORK,  NY  10017
Applicant Contact SHELDON STEINBERG
Correspondent
HOWMEDICA CORP.
235 EAST 42ND ST.
NEW YORK,  NY  10017
Correspondent Contact SHELDON STEINBERG
Regulation Number876.5900
Classification Product Code
EXB  
Date Received10/17/1984
Decision Date 11/29/1984
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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