SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM


Device Classification Name

external mandibular fixator and/or distractor

510(k) Number K080153
Device Name SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM
Applicant
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Applicant Contact andrea m tasker
Correspondent
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Correspodent Contact andrea m tasker
Regulation Number 872.4760
Classification Product Code
MQN  
Date Received 01/23/2008
Decision Date 05/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No