The following data is part of a premarket notification filed by El.en Electronic Engineering Spa with the FDA for Deka Smartxide2 Trio.
| Device ID | K181867 |
| 510k Number | K181867 |
| Device Name: | Deka Smartxide2 Trio |
| Classification | Powered Laser Surgical Instrument |
| Applicant | El.En Electronic Engineering Spa Via Baldanzese 17 Calenzano, IT 50041 |
| Contact | Paolo Peruzzi |
| Correspondent | Paolo Peruzzi El.En Electronic Engineering Spa Via Baldanzese 17 Calenzano, IT 50041 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-12 |
| Decision Date | 2018-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057017760573 | K181867 | 000 |
| 08057017760542 | K181867 | 000 |
| 08057017760603 | K181867 | 000 |