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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stents, drains and dilators for the biliary ducts
510(k) Number K915813
Device Name ACKRAD ERCP CONTRAST DELIVERY SET
Applicant
ACKRAD LABORATORIES
70 JACKSON DR.
CRANFORD,  NJ  07016
Applicant Contact BERNARD ACKERMAN
Correspondent
ACKRAD LABORATORIES
70 JACKSON DR.
CRANFORD,  NJ  07016
Correspondent Contact BERNARD ACKERMAN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/30/1991
Decision Date 03/11/1992
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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