Soniquence Reusable Bipolar Cable

Electrosurgical, Cutting & Coagulation & Accessories

Soniquence, LLC

The following data is part of a premarket notification filed by Soniquence, Llc with the FDA for Soniquence Reusable Bipolar Cable.

Pre-market Notification Details

Device IDK211946
510k NumberK211946
Device Name:Soniquence Reusable Bipolar Cable
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Soniquence, LLC 2477 Grand Avenue Baldwin,  NY  11510
ContactSuzanne Lucas
CorrespondentSuzanne Lucas
Soniquence, LLC 2477 Grand Avenue Baldwin,  NY  11510
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-23
Decision Date2021-07-16

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