FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K073616
Device Name FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE
Applicant
ELECTROMEDICS CO. LTD.
55 anderson avenue
moonachie, 
NJ 
07074

Applicant Contact john scholz
Correspondent
ELECTROMEDICS CO. LTD.
55 anderson avenue
moonachie, 
NJ 
07074

Correspodent Contact john scholz
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 12/26/2007
Decision Date 07/23/2008
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