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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 K844938
Device Name UNITED SKIN BARRIERS
Applicant
PFIZER, INC.
235 E 42ND ST.
NY,  NY  10017
Applicant Contact SHELDON STEINBERG
Correspondent
PFIZER, INC.
235 E 42ND ST.
NY,  NY  10017
Correspondent Contact SHELDON STEINBERG
Regulation Number876.5900
Classification Product Code
EXB  
Date Received12/20/1984
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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