Voyant Electrosurgical Generator

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 Electrosurgical Generator.

Pre-market Notification Details

Device IDK182244
510k NumberK182244
Device Name:Voyant Electrosurgical Generator
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Applied Medical Resources Corp. 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
ContactAndrew Nguyen
CorrespondentAndrew Nguyen
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 Received2018-08-20
Decision Date2018-10-11
Summary:summary

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