The following data is part of a premarket notification filed by Triworks Group Srl with the FDA for Agejet.
Device ID | K212472 |
510k Number | K212472 |
Device Name: | AgeJet |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Triworks Group SRL Via Don Giuseppe Mucciardi, 5 Campochiaro, IT 86020 |
Contact | Elio Piero Berchicci |
Correspondent | Matthew Brulport NEOconcepts LLC 2773 Alum Crossing Dr. Lewis Center, OH 43035 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-08-06 |
Decision Date | 2022-07-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08057168020083 | K212472 | 000 |
08057168020007 | K212472 | 000 |