KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM

Device Classification Name

external mandibular fixator and/or distractor

510(k) Number K034027
Device Name KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM
Applicant
KLS-MARTIN L.P.
11239-1 st. john’s ind. pkwy.
south
jacksonville, 
FL 
32246

Applicant Contact jennifer damato
Correspondent
KLS-MARTIN L.P.
11239-1 st. john’s ind. pkwy.
south
jacksonville, 
FL 
32246

Correspodent Contact jennifer damato
Regulation Number 872.4760
Classification Product Code
MQN  
Date Received 12/29/2003
Decision Date 02/27/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No