Voyant Open Fusion Device

Electrosurgical, Cutting & Coagulation & Accessories

Applied Medical Resources Corp.

The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Voyant Open Fusion Device.

Pre-market Notification Details

Device IDK201212
510k NumberK201212
Device Name:Voyant Open Fusion Device
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Applied Medical Resources Corp. 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
ContactSherif Nakhla
CorrespondentSherif Nakhla
Applied Medical Resources Corp. 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-05
Decision Date2020-06-05

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