AED MONOPOLAR LAP ACCESSORIES


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K081503
Device Name AED MONOPOLAR LAP ACCESSORIES
Applicant
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
22134 sherman way
canoga park, 
CA 
91303

Applicant Contact gayle m butler
Correspondent
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
22134 sherman way
canoga park, 
CA 
91303

Correspodent Contact gayle m butler
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 05/29/2008
Decision Date 09/25/2008
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