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 Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/27/2017 |
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
|
|
|