The following data is part of a premarket notification filed by El.en. Electronic Engineering Spa with the FDA for Minisilk Ft.
| Device ID | K082040 |
| 510k Number | K082040 |
| Device Name: | MINISILK FT |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | EL.EN. ELECTRONIC ENGINEERING SPA 17 VIA BALDANZESE Calenzano, IT 50041 |
| Contact | Andrea Tozzi |
| Correspondent | Andrea Tozzi EL.EN. ELECTRONIC ENGINEERING SPA 17 VIA BALDANZESE Calenzano, IT 50041 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-18 |
| Decision Date | 2009-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057017760443 | K082040 | 000 |