Ellusa Reusable Neutral Plates

Electrosurgical, Cutting & Coagulation & Accessories

Ellusa, LLC

The following data is part of a premarket notification filed by Ellusa, Llc with the FDA for Ellusa Reusable Neutral Plates.

Pre-market Notification Details

Device IDK222425
510k NumberK222425
Device Name:Ellusa Reusable Neutral Plates
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Ellusa, LLC 2473 Grand Avenue Baldwin,  NY  11510
ContactSuzanne Lucas
CorrespondentSuzanne Lucas
Ellusa, LLC 2473 Grand Avenue Baldwin,  NY  11510
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-11
Decision Date2022-09-08

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