1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES


Device Classification Name

plate, bone

510(k) Number K033121
Device Name 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES
Applicant
SYNTHES (USA)
p.o. box 1766
1690 russell road
paoli, 
PA 
19301 -1222

Applicant Contact lisa m boyle
Correspondent
SYNTHES (USA)
p.o. box 1766
1690 russell road
paoli, 
PA 
19301 -1222

Correspodent Contact lisa m boyle
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 09/30/2003
Decision Date 10/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No