Device Classification Name |
dura substitute
|
510(k) Number |
K161370 |
Device Name |
Durepair Dura Regeneration Matrix |
Applicant |
Medtronic Neurosurgery |
125 Cremona Drive |
Goleta,
CA
93117
|
|
Applicant Contact |
Manas Lele |
Correspondent |
Medtronic Neurosurgery |
125 Cremona Drive |
Goleta,
CA
93117
|
|
Correspondent Contact |
Manas Lele |
Regulation Number | 882.5910
|
Classification Product Code |
|
Date Received | 05/17/2016 |
Decision Date | 11/02/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|