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FDA 510(k) Applications Submitted by Halyard Health, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K173955
12/28/2017
Mic-Key* SF Over-the-Wire Stoma Measuring Device
Halyard Health, Inc.
K162930
10/19/2016
Aero Chrome* Select Breathable Performance Surgical Gowns
Halyard Health, Inc.
K153255
11/10/2015
Aero Chrome* Breathable Performance Surgical Gown
Halyard Health, Inc.
K143095
10/28/2014
MiniStim MS-IVB Peripheral Nerve Stimulator
Halyard Health, Inc.
K163236
11/17/2016
COOLIEF Cooled Radiofrequency Kit
Halyard Health, Inc.
K163461
12/09/2016
Coolief* Cooled RF Probe
Halyard Health, Inc.
K143287
11/17/2014
Fluidshield* Surgical Mask with Expanded Chamber
Halyard Health, Inc.
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