The following data is part of a premarket notification filed by Monteris Medical, Inc. with the FDA for Neuroblate System.
| Device ID | K143457 |
| 510k Number | K143457 |
| Device Name: | NeuroBlate System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MONTERIS MEDICAL, INC. 16305 36th Ave. North Suite 200 Plymouth, MN 55446 |
| Contact | Brooke Ren |
| Correspondent | Craig Coombs COOMBS MEDICAL DEVICE CONSULTING 1193 SHERMAN STREET Alameda, CA 94501 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-03 |
| Decision Date | 2015-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816589020465 | K143457 | 000 |
| 00816589020243 | K143457 | 000 |