COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W


Device Classification Name

powered laser surgical instrument

510(k) Number K080525
Device Name COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
Applicant
COOK UROLOGICAL, INC.
750 daniels way
bloomington, 
IN 
47404

Applicant Contact cindy foote
Correspondent
COOK UROLOGICAL, INC.
750 daniels way
bloomington, 
IN 
47404

Correspodent Contact cindy foote
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 02/26/2008
Decision Date 04/17/2008
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