Device Classification Name |
External Mandibular Fixator And/Or Distractor
|
510(k) Number |
K031708 |
Device Name |
OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM |
Applicant |
OSTEOMED L.P. |
3885 ARAPAHO RD. |
ADDISON,
TX
75001
|
|
Applicant Contact |
DAWN T HOLDERMAN |
Correspondent |
OSTEOMED L.P. |
3885 ARAPAHO RD. |
ADDISON,
TX
75001
|
|
Correspondent Contact |
DAWN T HOLDERMAN |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 06/02/2003 |
Decision Date | 11/03/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|