ATRILAZE LASER ABLATION SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K081457
Device Name ATRILAZE LASER ABLATION SYSTEM
Applicant
MEDICALCV, INC.
9725 south robert trail
inver grove heights, 
MN 
55077

Applicant Contact kirk s honour
Correspondent
MEDICALCV, INC.
9725 south robert trail
inver grove heights, 
MN 
55077

Correspodent Contact kirk s honour
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 05/23/2008
Decision Date 08/08/2008
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