Medical RF

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 Medical Rf.

Pre-market Notification Details

Device IDK192621
510k NumberK192621
Device Name:Medical RF
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Triworks Group SRL Via L.Belpulsi 3 Campobasso,  IT 86100
ContactElio Piero Berchicci
CorrespondentParul Chansoria
Elexes 453 West San Carlos Street San Jose,  CA  95110
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-23
Decision Date2020-11-06

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