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 |