SYNTHES CRANIOFACIAL PLATES


Device Classification Name

plate, bone

510(k) Number K021642
Device Name SYNTHES CRANIOFACIAL PLATES
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 05/20/2002
Decision Date 08/14/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No