Device Classification Name |
Cover, Burr Hole
|
510(k) Number |
K160739 |
Device Name |
Cranial COVER |
Applicant |
Neos Surgery S.L. |
Parc Tecnologic del Valles, C/Ceramistes, 2 |
Cerdanyola del Valles,
ES
08290
|
|
Applicant Contact |
Eduard Garcia |
Correspondent |
M Squared Associates, Inc. |
575 Eighth Avenue, Suite 1212 |
New York,
NY
10018
|
|
Correspondent Contact |
Marcos Velez-Duran |
Regulation Number | 882.5250
|
Classification Product Code |
|
Date Received | 03/17/2016 |
Decision Date | 06/12/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|