Device Classification Name |
External Mandibular Fixator And/Or Distractor
|
510(k) Number |
K080542 |
Device Name |
DISTRAX |
Applicant |
JOHN W. KING |
800 EAST LEIGH STREET |
SUITE 206-5 |
RICHMOND,
VA
23219
|
|
Applicant Contact |
EMILY B ROSSITER |
Correspondent |
JOHN W. KING |
800 EAST LEIGH STREET |
SUITE 206-5 |
RICHMOND,
VA
23219
|
|
Correspondent Contact |
EMILY B ROSSITER |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 02/27/2008 |
Decision Date | 12/15/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|