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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 K152771
Device Name SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long
Applicant
SUMITOMO BAKELITE CO., LTD.
5-8, HIGASHI-SHINAGAWA 2- CHOME, SHINAGAWA-KU,
TOKYO,  JP 140-0002
Applicant Contact SHIRO AGEHAMA
Correspondent
VAUPELL CORP.
101 HP ALMGREN DR.
AGAWAM,  MA  01001
Correspondent Contact MICHAEL BEELTJE
Regulation Number876.4300
Classification Product Code
KNS  
Date Received09/25/2015
Decision Date 06/17/2016
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
Recalls CDRH Recalls
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