NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR


Device Classification Name

plate, bone

510(k) Number K021342
Device Name NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR
Original Applicant
OSTEOMEDICS, INC.
809 carter ln.
paramus, 
NJ 
07652

Original Contact albert enayati
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 04/29/2002
Decision Date 08/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No