Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K160041 |
Device Name |
Cobbra RF Tissue Dissector |
Applicant |
ELLIQUENCE LLC. |
2455 Grand Avenue |
Baldwin,
NY
11510
|
|
Applicant Contact |
PAUL D. BUHRKE |
Correspondent |
ELLIQUENCE LLC. |
2455 Grand Avenue |
Baldwin,
NY
11510
|
|
Correspondent Contact |
PAUL D. BUHRKE |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 01/08/2016 |
Decision Date | 03/07/2016 |
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
|