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FDA 510(k) Applications Submitted by Kimberly Lewis
FDA 510(k) Number
Submission Date
Device Name
Applicant
K200522
03/02/2020
AERO CHROME* Breathable Performance Surgical Gowns
O&M Halyard, Inc
K210688
03/08/2021
AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown
O&M Halyard, Inc
K192362
08/30/2019
Aero Blue Performance Surgical Gowns
O&M Halyard, Inc.
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