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
|
|
Correspondent Contact |
PIEDAD PENA |
Regulation Number | 882.5330
|
Classification Product Code |
|
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
|
|
|