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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 K963051
FOIA Releasable 510(k) K963051
Device Name ERCP CANNULA
Applicant
United States Endoscopy Group, Inc.
9330 Progress Pkwy.
Mentor,  OH  44060
Applicant Contact GRETCHEN YOUNKER-COHEN
Correspondent
United States Endoscopy Group, Inc.
9330 Progress Pkwy.
Mentor,  OH  44060
Correspondent Contact GRETCHEN YOUNKER-COHEN
Regulation Number876.1500
Classification Product Code
ODD  
Date Received08/06/1996
Decision Date 03/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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