The following data is part of a premarket notification filed by Brera Medical Inc with the FDA for Plasmage System.
| Device ID | K202106 |
| 510k Number | K202106 |
| Device Name: | Plasmage System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Brera Medical Inc 19 Kramas Lane Northwood, NH 03261 |
| Contact | Felix Feldchtein |
| Correspondent | Paul Dunleavy Brera Medical Inc 19 Kramas Lane Northwood, NH 03261 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-29 |
| Decision Date | 2022-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860008655806 | K202106 | 000 |