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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement, stomal appliance, ostomy
510(k) Number K844341
Device Name UNITED SKIN BARRIER PASTE
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
EZR  
Date Received11/08/1984
Decision Date 01/18/1985
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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