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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 K860990
Device Name ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY
Applicant
ENDOVATIONS
895 POPLAR CHURCH RD.
CAMP HILL,  PA  17011
Applicant Contact LIFTON, MD
Correspondent
ENDOVATIONS
895 POPLAR CHURCH RD.
CAMP HILL,  PA  17011
Correspondent Contact LIFTON, MD
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/17/1986
Decision Date 05/13/1986
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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