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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cholangiography
510(k) Number K926143
Device Name ANGIOLAPCATH CHOLANGIOGRAPHY KIT
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact MARCIA C LEATHAM
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact MARCIA C LEATHAM
Regulation Number878.4200
Classification Product Code
GBZ  
Date Received12/07/1992
Decision Date 07/07/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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