ELLIPSE MULTIFLEX


Device Classification Name

powered laser surgical instrument

510(k) Number K081408
Device Name ELLIPSE MULTIFLEX
Applicant
ELLIPSE A/S
agern alle 11
hoersholm, 

DK

dk-2070

Applicant Contact ole kofod
Correspondent
ELLIPSE A/S
agern alle 11
hoersholm, 

DK

dk-2070

Correspodent Contact ole kofod
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 05/19/2008
Decision Date 10/17/2008
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