The following data is part of a premarket notification filed by Minnetronix Neuro, Inc. with the FDA for Mindseye Expandable Port.
| Device ID | K202072 |
| 510k Number | K202072 |
| Device Name: | MindsEye Expandable Port |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | Minnetronix Neuro, INC. 1635 Energy Park Drive St. Paul, MN 55108 |
| Contact | Matt Adams |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-07-27 |
| Decision Date | 2020-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003476826 | K202072 | 000 |
| 00860003476819 | K202072 | 000 |
| 00860003476802 | K202072 | 000 |