TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION


Device Classification Name

external mandibular fixator and/or distractor

510(k) Number K002152
Device Name TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION
Original Applicant
KLS-MARTIN L.P.
3234 ella ln.
new port richey, 
FL 
34655

Original Contact art ward
Regulation Number 872.4760
Classification Product Code
MQN  
Date Received 07/17/2000
Decision Date 10/10/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No