Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K181622 |
Device Name |
StrataMR guider tool |
Applicant |
Medtronic Neurosurgery |
125 Cremona Dr |
Goleta,
CA
93117
|
|
Applicant Contact |
Xiaojian Sun |
Correspondent |
Medtronic Neurosurgery |
125 Cremona Dr |
Goleta,
CA
93117
|
|
Correspondent Contact |
Xiaojian Sun |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 06/20/2018 |
Decision Date | 10/01/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|