DORNIER MEDILAS D 30 LASER, MEDILAS D 1064


Device Classification Name

powered laser surgical instrument

510(k) Number K080959
Device Name DORNIER MEDILAS D 30 LASER, MEDILAS D 1064
Applicant
DORNIER MEDTECH AMERICA, INC.
1155 roberts blvd.
kennesaw, 
GA 
30144

Applicant Contact theron gober
Correspondent
DORNIER MEDTECH AMERICA, INC.
1155 roberts blvd.
kennesaw, 
GA 
30144

Correspodent Contact theron gober
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 04/03/2008
Decision Date 06/27/2008
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