DISTRAX


Device Classification Name

external mandibular fixator and/or distractor

510(k) Number K080542
Device Name DISTRAX
Applicant
JOHN W. KING
800 east leigh street
suite 206-5
richmond, 
VA 
23219

Applicant Contact emily b rossiter
Correspondent
JOHN W. KING
800 east leigh street
suite 206-5
richmond, 
VA 
23219

Correspodent Contact emily b rossiter
Regulation Number 872.4760
Classification Product Code
MQN  
Date Received 02/27/2008
Decision Date 12/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No