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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K962346
Device Name PAPILLOTOME
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
9300 PROGRESS PKWY.
MENTOR,  OH  44060
Applicant Contact GRETCHEN YOUNKER
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
9300 PROGRESS PKWY.
MENTOR,  OH  44060
Correspondent Contact GRETCHEN YOUNKER
Regulation Number876.4300
Classification Product Code
KNS  
Date Received06/18/1996
Decision Date 08/08/1996
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
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