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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 K851398
Device Name BARD PERISTOMAL PASTE
Applicant
C.R Bard, Inc.
111 Spring St.
Murray Hill,  NJ  07974
Applicant Contact BOGDAN DZIURZYNSKI
Correspondent
C.R Bard, Inc.
111 Spring St.
Murray Hill,  NJ  07974
Correspondent Contact BOGDAN DZIURZYNSKI
Regulation Number876.5900
Classification Product Code
EXB  
Date Received04/09/1985
Decision Date 05/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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