SELLAS


Device Classification Name

powered laser surgical instrument

510(k) Number K080382
Device Name SELLAS
Applicant
DINONA CO., LTD.
13 red fox lane
littleton, 
CO 
80127

Applicant Contact kevin walls
Correspondent
DINONA CO., LTD.
13 red fox lane
littleton, 
CO 
80127

Correspodent Contact kevin walls
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 02/13/2008
Decision Date 09/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No