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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K182520
Device Name Flexible Overtube
Applicant
Sumitomo Bakelite Co., Ltd.
5-8, Higashi-Shinagawa 2-Chome
Shinagawa-Ku,  JP 1400002
Applicant Contact Shiro Agehama
Correspondent
Mic International Corp.
4-1-17 Hongo
Bunkyo-Ku,  JP 1130033
Correspondent Contact Izumi Maruo
Regulation Number876.1500
Classification Product Code
FED  
Date Received09/13/2018
Decision Date 05/15/2019
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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