PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K080197
Device Name PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
Applicant
PLASMA SURGICAL, LTD.
brunel road
theale, berkshire, 

GB

rg7 4aq

Applicant Contact peter gibson
Correspondent
PLASMA SURGICAL, LTD.
brunel road
theale, berkshire, 

GB

rg7 4aq

Correspodent Contact peter gibson
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 01/25/2008
Decision Date 06/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls