The following data is part of a premarket notification filed by Monteris Medical, Inc. with the FDA for Neuroblate System.
| Device ID | K120561 |
| 510k Number | K120561 |
| Device Name: | NEUROBLATE SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MONTERIS MEDICAL, INC. 100 - 78 Innovation Drive Winnipeg, CA R3t 6c2 |
| Contact | Jeff Wilson |
| Correspondent | Jeff Wilson MONTERIS MEDICAL, INC. 100 - 78 Innovation Drive Winnipeg, CA R3t 6c2 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-24 |
| Decision Date | 2013-04-01 |
| Summary: | summary |