SOLA 700,SOLA 500, SOLA 300


Device Classification Name

lamp, surgical

510(k) Number K010724
Device Name SOLA 700,SOLA 500, SOLA 300
Original Applicant
DRAGER MEDIZINTECHNIK GMBH
3135 quarry rd.
telford, 
PA 
18969

Original Contact james j brennan
Regulation Number 878.4580
Classification Product Code
FTD  
Date Received 03/12/2001
Decision Date 06/07/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls