Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K082568 |
Device Name |
SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE |
Applicant |
BOVIE MEDICAL |
7100 30TH AVE. NORTH |
ST. PETERSBURG,
FL
33710 -2902
|
|
Applicant Contact |
RICHARD A KOZLOFF |
Correspondent |
BOVIE MEDICAL |
7100 30TH AVE. NORTH |
ST. PETERSBURG,
FL
33710 -2902
|
|
Correspondent Contact |
RICHARD A KOZLOFF |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/04/2008 |
Decision Date | 11/17/2008 |
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
|