Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K151743 |
Device Name |
THUNDERBEAT Open Fine Jaw |
Applicant |
OLYMPUS MEDICAL SYSTEMS CORP. |
2951 ISHIKAWA-CHO |
HACHIOJI-SHI,
JP
192-8507
|
|
Applicant Contact |
TOSHIYUKI NAKAJIMA |
Correspondent |
GYRUS ACMI INC. |
136 TURNPIKE ROAD |
SOUTHBOROUGH,
MA
01772
|
|
Correspondent Contact |
GRAHAM A. L. BAILLIE |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/29/2015 |
Decision Date | 02/26/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|