Device Classification Name |
plate, cranioplasty, preformed, alterable
|
510(k) Number |
K122049 |
Device Name |
NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM |
Applicant |
KINAMED, INC. |
820 FLYNN RD. |
CAMARILLO,
CA
93012
|
|
Applicant Contact |
HEATHER NEELY |
Correspondent |
KINAMED, INC. |
820 FLYNN RD. |
CAMARILLO,
CA
93012
|
|
Correspondent Contact |
HEATHER NEELY |
Regulation Number | 882.5320
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/12/2012 |
Decision Date | 04/05/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|