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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name biliary catheter for stone removal that may also allow for irrigation and contrast injection
510(k) Number K915506
Device Name LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
9300 PROGRESS PKWY.
MENTOR,  OH  44060
Applicant Contact LISA M SCHOLZ
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
9300 PROGRESS PKWY.
MENTOR,  OH  44060
Correspondent Contact LISA M SCHOLZ
Regulation Number876.5010
Classification Product Code
GCA  
Date Received12/09/1991
Decision Date 03/06/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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