The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Thunderbeat Open Fine Jaw.
| Device ID | K151743 |
| 510k Number | K151743 |
| Device Name: | THUNDERBEAT Open Fine Jaw |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 2951 ISHIKAWA-CHO Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Graham A. L. Baillie GYRUS ACMI INC. 136 TURNPIKE ROAD Southborough, MA 01772 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-29 |
| Decision Date | 2016-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170343343 | K151743 | 000 |