LEFORTE SYSTEM BONE PLATE & SCREW


Device Classification Name

plate, bone

510(k) Number K112457
Device Name LEFORTE SYSTEM BONE PLATE & SCREW
Applicant
ARKIN CONSULTING GROUP
1733 canton lane
marietta, 
GA 
30062 -2679

Applicant Contact paul sumner
Correspondent
ARKIN CONSULTING GROUP
1733 canton lane
marietta, 
GA 
30062 -2679

Correspodent Contact paul sumner
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 08/26/2011
Decision Date 05/18/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No