Device Classification Name |
Plate, Cranioplasty, Preformed, Non-Alterable
|
510(k) Number |
K033868 |
Device Name |
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS |
Applicant |
SYNTHES (USA) |
1690 RUSSELL RD. |
PAOLI,
PA
19301
|
|
Applicant Contact |
LISA M BOYLE |
Correspondent |
SYNTHES (USA) |
1690 RUSSELL RD. |
PAOLI,
PA
19301
|
|
Correspondent Contact |
LISA M BOYLE |
Regulation Number | 882.5330
|
Classification Product Code |
|
Date Received | 12/12/2003 |
Decision Date | 06/21/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|