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 | K150112 |
| 510k Number | K150112 |
| 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 | Maurizio Pantaleoni ISEMED Srl via A. BONETTI 3/A 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 | 2015-01-20 |
| Decision Date | 2015-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08058983742464 | K150112 | 000 |
| 08058983745953 | K150112 | 000 |
| 08058983746189 | K150112 | 000 |
| 08058983744420 | K150112 | 000 |
| 08058983744390 | K150112 | 000 |
| 08058983741054 | K150112 | 000 |
| 08058983741160 | K150112 | 000 |
| 08058983742211 | K150112 | 000 |
| 08058983742174 | K150112 | 000 |
| 08033055147200 | K150112 | 000 |
| 08058983740941 | K150112 | 000 |
| 08058983742068 | K150112 | 000 |
| 08058983742457 | K150112 | 000 |
| 08058983745366 | K150112 | 000 |