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FDA 510(k) Applications Submitted by John O'Dea
FDA 510(k) Number
Submission Date
Device Name
Applicant
K230474
02/22/2023
EVA5 Insufflator
Palliare Ltd.
K160725
03/16/2016
EndoFLIP
CROSPON LTD.
K040862
04/02/2004
GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM
CARADYNE, LTD.
K202799
09/23/2020
EVA15
Palliare Ltd.
K222901
09/23/2022
EVA15 insufflator
Palliare Ltd.
K183072
11/05/2018
EndoFLIP System
Crospon Ltd
K053168
11/14/2005
BIPAP FOCUS
RESPIRONICS (IRELAND) LIMITED
K193520
12/19/2019
EVA 15 Insufflator
Palliare Ltd.
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