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FDA 510(k) Applications Submitted by Mike Romaniw
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180538
02/28/2018
gammaCore Sapphire
electroCore, LLC
K171306
05/03/2017
gammaCore-S
electroCore, LLC
K211856
06/16/2021
gammaCore Sapphire
Electrocore, Inc.
K191830
07/09/2019
gammaCore Sapphire
Electrocore, Inc.
K172270
07/28/2017
gammaCore-2
eletroCore, LLC
K182369
08/31/2018
gammaCore Sapphire
Electrocore, Inc.
DEN150048
10/16/2015
gammaCore Non-invasive Vagus Nerve Stimulator
electroCore, LLC
K173442
11/06/2017
gammaCore-S
electroCore, LLC
K203546
12/04/2020
gammaCore Sapphire
Electrocore, Inc.
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