Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K152777 |
Device Name |
Bovie Disposable Bipolar Ablator |
Applicant |
BOVIE MEDICAL CORPORATION |
5115 ULMERTON ROAD |
CLEARWATER,
FL
33760
|
|
Applicant Contact |
BRIAN KUNST |
Correspondent |
BOVIE MEDICAL CORPORATION |
5115 ULMERTON ROAD |
CLEARWATER,
FL
33760
|
|
Correspondent Contact |
BRIAN KUNST |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/25/2015 |
Decision Date | 01/15/2016 |
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
|
Recalls |
CDRH Recalls
|