The following data is part of a premarket notification filed by Mattioli Engineering, Srl with the FDA for Multiple Co2 Laers.
| Device ID | K941838 |
| 510k Number | K941838 |
| Device Name: | MULTIPLE CO2 LAERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MATTIOLI ENGINEERING, SRL VIALE MACHIAVELLI, 2/A Florence, IT 50125 |
| Contact | Gian Franco Bernabei |
| Correspondent | Gian Franco Bernabei MATTIOLI ENGINEERING, SRL VIALE MACHIAVELLI, 2/A Florence, IT 50125 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-13 |
| Decision Date | 1994-12-15 |