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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 K862631
Device Name BARD IRYFIX(TM) STOMA CAP
Applicant
C.R. BARD, INC.
111 SPRING ST.
MURRAY HILL,  NJ  07974
Applicant Contact JOSEPH KICEINA
Correspondent
C.R. BARD, INC.
111 SPRING ST.
MURRAY HILL,  NJ  07974
Correspondent Contact JOSEPH KICEINA
Regulation Number876.5900
Classification Product Code
EXB  
Date Received07/10/1986
Decision Date 10/16/1986
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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