AgeJet

Electrosurgical, Cutting & Coagulation & Accessories

Triworks Group SRL

The following data is part of a premarket notification filed by Triworks Group Srl with the FDA for Agejet.

Pre-market Notification Details

Device IDK212472
510k NumberK212472
Device Name:AgeJet
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Triworks Group SRL Via Don Giuseppe Mucciardi, 5 Campochiaro,  IT 86020
ContactElio Piero Berchicci
CorrespondentMatthew Brulport
NEOconcepts LLC 2773 Alum Crossing Dr. Lewis Center,  OH  43035
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-06
Decision Date2022-07-07

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