Device Classification Name |
plate, bone
|
510(k) Number |
K091144 |
Device Name |
SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES |
Applicant |
SYNTHES (USA) |
1301 GOSHEN PKWY. |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
ANDREA TASKER |
Correspondent |
SYNTHES (USA) |
1301 GOSHEN PKWY. |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
ANDREA TASKER |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 04/20/2009 |
Decision Date | 08/25/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|