SYNTHES MIDFACE DISTRACTOR


Device Classification Name

plate, bone

510(k) Number K022005
Device Name SYNTHES MIDFACE DISTRACTOR
Original Applicant
SYNTHES (USA)
1690 russell rd.
paoli, 
PA 
19301

Original Contact matthew m hull
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 06/19/2002
Decision Date 09/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No