The following data is part of a premarket notification filed by Monteris Medical, Inc. with the FDA for Neuroblate System.
| Device ID | K201056 |
| 510k Number | K201056 |
| Device Name: | NeuroBlate System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Monteris Medical, Inc. 14755 27th Avenue North; Suite C Plymouth, MN 55447 |
| Contact | David H. Mueller |
| Correspondent | David H. Mueller Monteris Medical, Inc. 14755 27th Avenue North; Suite C Plymouth, MN 55447 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-21 |
| Decision Date | 2020-08-21 |