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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gastroscope and accessories, flexible/rigid
510(k) Number K173004
Device Name SB Soft Hood - Straight type, SB Soft Hood - Undercut type
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
FDS  
Date Received09/27/2017
Decision Date 05/08/2018
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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