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 |