Device Classification Name |
retractor, self-retaining, for neurosurgery
|
510(k) Number |
K202072 |
Device Name |
MindsEye Expandable Port |
Applicant |
Minnetronix Neuro, INC. |
1635 Energy Park Drive |
St. Paul,
MN
55108
|
|
Applicant Contact |
Matt Adams |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 882.4800
|
Classification Product Code |
|
Date Received | 07/27/2020 |
Decision Date | 08/26/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|