Eustachi Ear Pressure Relief Device

Device, Inflation, Middle Ear

Exercore, LLC

The following data is part of a premarket notification filed by Exercore, Llc with the FDA for Eustachi Ear Pressure Relief Device.

Pre-market Notification Details

Device IDK203754
510k NumberK203754
Device Name:Eustachi Ear Pressure Relief Device
ClassificationDevice, Inflation, Middle Ear
Applicant Exercore, LLC 8170 Old Carriage Court N, Suite 200 Shakopee,  MN  55379
ContactKevin Connelly
CorrespondentLisa Pritchard
DuVal & Associates, P.A. 825 Nicollet Mall, Suite 1840 Minneapolis,  MN  55402
Product CodeMJV  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-23
Decision Date2021-02-19

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