The following data is part of a premarket notification filed by Sumitomo Bakelite Co., Ltd with the FDA for Sb Soft Hood - Straight Type, Sb Soft Hood - Undercut Type.
| Device ID | K173004 |
| 510k Number | K173004 |
| Device Name: | SB Soft Hood - Straight Type, SB Soft Hood - Undercut Type |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | Sumitomo Bakelite Co., Ltd 5-8, Higashi-Shinagawa 2-chome Shinagawa-ku, JP 1400002 |
| Contact | Shiro Agehama |
| Correspondent | Izumi Maruo MIC International Corp. 4-1-17 Hongo Bunkyo-ku, JP 1130033 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2018-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24545499068914 | K173004 | 000 |
| 24545499068907 | K173004 | 000 |
| 24545499068891 | K173004 | 000 |
| 24545499068884 | K173004 | 000 |
| 24545499068877 | K173004 | 000 |
| 24545499068860 | K173004 | 000 |