The following data is part of a premarket notification filed by Sumitomo Bakelite Co., Ltd with the FDA for Flexible Overtube.
| Device ID | K182520 |
| 510k Number | K182520 |
| Device Name: | Flexible Overtube |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| 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 | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-13 |
| Decision Date | 2019-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04545499070098 | K182520 | 000 |