Device Classification Name |
plate, bone
|
510(k) Number |
K080331 |
Device Name |
SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM |
Applicant |
SYNTHES (USA) |
1302 WRIGHTS LANE EAST |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
AMNON TALMOR |
Correspondent |
SYNTHES (USA) |
1302 WRIGHTS LANE EAST |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
AMNON TALMOR |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 02/06/2008 |
Decision Date | 04/30/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|