OSTEOMED CRANIAL DISTRACTION SYSTEM


Device Classification Name

cranial distraction system

510(k) Number K121304
Device Name OSTEOMED CRANIAL DISTRACTION SYSTEM
Applicant
OSTEOMED
3885 arapaho rd
addison, 
TX 
75001

Applicant Contact piedad pena
Correspondent
OSTEOMED
3885 arapaho rd
addison, 
TX 
75001

Correspodent Contact piedad pena
Regulation Number 882.5330
Classification Product Code
PBJ  
Date Received 05/01/2012
Decision Date 08/22/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No