Voyant Fine Fusion Device (EB230)

Electrosurgical, Cutting & Coagulation & Accessories

Applied Medical

The following data is part of a premarket notification filed by Applied Medical with the FDA for Voyant Fine Fusion Device (eb230).

Pre-market Notification Details

Device IDK202818
510k NumberK202818
Device Name:Voyant Fine Fusion Device (EB230)
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Applied Medical 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
ContactBlake Stacy
CorrespondentBlake Stacy
Applied Medical 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-24
Decision Date2021-12-16

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