Device Classification Name |
Plate, Cranioplasty, Preformed, Alterable
|
510(k) Number |
K974206 |
Device Name |
SYNTHES CRANIAL SPRING CLIP (CSC) |
Applicant |
SYNTHES (USA) |
P.O. BOX 1766 |
1690 RUSSELL ROAD |
PAOLI,
PA
19301 -1222
|
|
Applicant Contact |
SHERI MUSGNUNG |
Correspondent |
SYNTHES (USA) |
P.O. BOX 1766 |
1690 RUSSELL ROAD |
PAOLI,
PA
19301 -1222
|
|
Correspondent Contact |
SHERI MUSGNUNG |
Regulation Number | 882.5320
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/10/1997 |
Decision Date | 03/16/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|