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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 K854726
Device Name MEDI-WIPES UNITED ANTISEPTIC SKIN PREP
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 Received11/25/1985
Decision Date 02/24/1986
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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