Device Classification Name |
Plate, Bone
|
510(k) Number |
K033121 |
Device Name |
1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES |
Applicant |
SYNTHES (USA) |
P.O. BOX 1766 |
1690 RUSSELL ROAD |
PAOLI,
PA
19301 -1222
|
|
Applicant Contact |
LISA M BOYLE |
Correspondent |
SYNTHES (USA) |
P.O. BOX 1766 |
1690 RUSSELL ROAD |
PAOLI,
PA
19301 -1222
|
|
Correspondent Contact |
LISA M BOYLE |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 09/30/2003 |
Decision Date | 10/20/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|