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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
510(k) Number K845018
FOIA Releasable 510(k) K845018
Device Name DAVOL ERCP CANNULA
Applicant
C.R. Bard, Inc.
111 Spring St.
Murray Hill,  NJ  07974
Applicant Contact CATHERINE V BEATH
Correspondent
C.R. Bard, Inc.
111 Spring St.
Murray Hill,  NJ  07974
Correspondent Contact CATHERINE V BEATH
Regulation Number876.1500
Classification Product Code
ODD  
Date Received12/26/1984
Decision Date 01/15/1985
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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