Plasma IQ

Electrosurgical, Cutting & Coagulation & Accessories

Neauvia North America, Inc

The following data is part of a premarket notification filed by Neauvia North America, Inc with the FDA for Plasma Iq.

Pre-market Notification Details

Device IDK192813
510k NumberK192813
Device Name:Plasma IQ
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Neauvia North America, Inc 8480 Honeycutt Rd Raleigh,  NC  27615
ContactMisty Williams
CorrespondentMisty Williams
Neauvia North America, Inc 8480 Honeycutt Rd Raleigh,  NC  27615
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-01
Decision Date2020-03-06

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