Device Classification Name |
Plate, Cranioplasty, Preformed, Non-Alterable
|
510(k) Number |
K971252 |
Device Name |
SEVRAIN CRANIAL CLAMP |
Applicant |
IKONOS CORP. |
320 S.W. 6TH. AVE., 2ND. FL. |
PORTLAND,
OR
97204
|
|
Applicant Contact |
CHARLES ALBERT |
Correspondent |
IKONOS CORP. |
320 S.W. 6TH. AVE., 2ND. FL. |
PORTLAND,
OR
97204
|
|
Correspondent Contact |
CHARLES ALBERT |
Regulation Number | 882.5330
|
Classification Product Code |
|
Date Received | 04/03/1997 |
Decision Date | 07/06/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|