Voyant Fine Fusion Device

Electrosurgical, Cutting & Coagulation & Accessories

APPLIED MEDICAL RESOURCES

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

Pre-market Notification Details

Device IDK143536
510k NumberK143536
Device Name:Voyant Fine Fusion Device
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant APPLIED MEDICAL RESOURCES 22872 AVENIDA EMPRESA Rancho Santa Margarita,  CA  92688
ContactJessica Cho
CorrespondentJessica Cho
APPLIED MEDICAL RESOURCES 22872 AVENIDA EMPRESA Rancho Santa Margarita,  CA  92688
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-15
Decision Date2015-04-16
Summary:summary

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