MEDILAS H RFID LASER FIBER


Device Classification Name

powered laser surgical instrument

510(k) Number K121938
Device Name MEDILAS H RFID LASER FIBER
Applicant
DORNIER MEDTECH AMERICA, INC.
1155 roberts blvd.
kennesaw, 
GA 
30144

Applicant Contact john hoffer
Correspondent
DORNIER MEDTECH AMERICA, INC.
1155 roberts blvd.
kennesaw, 
GA 
30144

Correspodent Contact john hoffer
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 07/02/2012
Decision Date 08/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized