The following data is part of a premarket notification filed by Triworks Group Srl with the FDA for Medical Rf.
| Device ID | K192621 |
| 510k Number | K192621 |
| Device Name: | Medical RF |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Triworks Group SRL Via L.Belpulsi 3 Campobasso, IT 86100 |
| Contact | Elio Piero Berchicci |
| Correspondent | Parul Chansoria Elexes 453 West San Carlos Street San Jose, CA 95110 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-23 |
| Decision Date | 2020-11-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057168020090 | K192621 | 000 |
| 08057168020014 | K192621 | 000 |