KLS MARTIN XTERNAL FIXATOR


Device Classification Name

external mandibular fixator and/or distractor

510(k) Number K072764
Device Name KLS MARTIN XTERNAL FIXATOR
Applicant
KLS MARTIN L.P.
11239 st. johns industrial
parkway south
jacksonville, 
FL 
32246

Applicant Contact tom faucett
Correspondent
KLS MARTIN L.P.
11239 st. johns industrial
parkway south
jacksonville, 
FL 
32246

Correspodent Contact tom faucett
Regulation Number 872.4760
Classification Product Code
MQN  
Date Received 09/28/2007
Decision Date 12/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No