NORMED BONE TRANSPORT DISTRACTION DEVICE


Device Classification Name

plate, bone

510(k) Number K021341
Device Name NORMED BONE TRANSPORT DISTRACTION DEVICE
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