The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Mdk Multi-applications Platform.
| Device ID | K130256 |
| 510k Number | K130256 |
| Device Name: | MDK MULTI-APPLICATIONS PLATFORM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Quanta System SpA VIA IV NOVEMBRE 116 Solbiate Olona (va), IT 21058 |
| Contact | Maurizio Bianchi |
| Correspondent | Maurizio Bianchi Quanta System SpA VIA IV NOVEMBRE 116 Solbiate Olona (va), IT 21058 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-01 |
| Decision Date | 2013-07-02 |
| Summary: | summary |