The following data is part of a premarket notification filed by Espansione Marketing Spa with the FDA for Epi-c Plus.
| Device ID | K070494 |
| 510k Number | K070494 |
| Device Name: | EPI-C PLUS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ESPANSIONE MARKETING SPA VIA CALINDRI, 50 San Lazzaro Di Savena (bo), IT 40068 |
| Contact | Guido Bonapace |
| Correspondent | Guido Bonapace ESPANSIONE MARKETING SPA VIA CALINDRI, 50 San Lazzaro Di Savena (bo), IT 40068 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-20 |
| Decision Date | 2007-05-01 |
| Summary: | summary |