BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K112233
Device Name BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE
Applicant
BOVIE MEDICAL CORPORATION
5115 ulmerton road
clearwater, 
FL 
33760 -0000

Applicant Contact richard a kozloff
Correspondent
BOVIE MEDICAL CORPORATION
5115 ulmerton road
clearwater, 
FL 
33760 -0000

Correspodent Contact richard a kozloff
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 08/04/2011
Decision Date 01/27/2012
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