Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K134054 |
Device Name |
BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR |
Applicant |
BOVIE MEDICAL CORPORATION |
5115 ULMERTON ROAD |
CLEARWATER,
FL
33760 -4004
|
|
Applicant Contact |
RICHARD A KOZLOFF |
Correspondent |
BOVIE MEDICAL CORPORATION |
5115 ULMERTON ROAD |
CLEARWATER,
FL
33760 -4004
|
|
Correspondent Contact |
RICHARD A KOZLOFF |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 12/31/2013 |
Decision Date | 03/17/2014 |
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
|