The following data is part of a premarket notification filed by Hs Hospital Service Spa with the FDA for Hs Amica Devices Family.
| Device ID | K182605 |
| 510k Number | K182605 |
| Device Name: | HS AMICA Devices Family |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | HS Hospital Service SPA Via A. Vacchi, 23/25 Aprilia, IT 04011 |
| Contact | Laura Lenzi |
| Correspondent | Silvia Scarpellini Isemed Srl Via P. Togliatti 19/X Imola, IT 40026 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-21 |
| Decision Date | 2019-10-28 |
| Summary: | summary |