Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K093025 |
Device Name |
BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES |
Applicant |
BOVIE MEDICAL CORPORATION |
5115 Ulmerton Road |
Clearwater,
FL
33760 -0000
|
|
Applicant Contact |
RICHARD KOZLOFF |
Correspondent |
BOVIE MEDICAL CORPORATION |
5115 Ulmerton Road |
Clearwater,
FL
33760 -0000
|
|
Correspondent Contact |
RICHARD KOZLOFF |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/29/2009 |
Decision Date | 12/22/2009 |
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
|