The following data is part of a premarket notification filed by Monteris Medical, Inc. with the FDA for Monteris Medical Neuroblate System.
| Device ID | K131278 |
| 510k Number | K131278 |
| Device Name: | MONTERIS MEDICAL NEUROBLATE SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MONTERIS MEDICAL, INC. 1193 SHERMAN ST Alameda, CA 94501 |
| Contact | Craig Coombs |
| Correspondent | Craig Coombs MONTERIS MEDICAL, INC. 1193 SHERMAN ST Alameda, CA 94501 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-06 |
| Decision Date | 2013-07-11 |
| Summary: | summary |