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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 K950700
FOIA Releasable 510(k) K950700
Device Name BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA
Applicant
C.R. Bard, Inc.
200 Ames Pond Dr.
Tewksbury,  MA  01876
Applicant Contact JOHN A BELUCIA
Correspondent
C.R. Bard, Inc.
200 Ames Pond Dr.
Tewksbury,  MA  01876
Correspondent Contact JOHN A BELUCIA
Regulation Number876.1500
Classification Product Code
ODD  
Date Received02/15/1995
Decision Date 04/27/1995
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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