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FDA 510(k) Applications Submitted by Tina O'Brien
FDA 510(k) Number
Submission Date
Device Name
Applicant
K200413
02/19/2020
Symphony
Aroa Biosurgery Ltd.
K200502
02/28/2020
Myriad Particles
Aroa Biosurgery Ltd.
K131744
06/13/2013
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE
TERUMO BCT, INC..
K181935
07/19/2018
Endoform Reconstructive Template - Non Absorbable
Aroa Biosurgery Ltd.
K172318
08/01/2017
Endoform Silver Dermal Template
Aroa Biosurgery
K132429
08/05/2013
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET
TERUMO BCT, INC..
K162582
09/15/2016
HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
FISHER & PAYKEL HEALTHCARE
K082966
10/06/2008
PB 540 VENTILATOR
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.
K223373
11/04/2022
EnivoÖ
Aroa Biosurgery Ltd.
K113480
11/23/2011
SPECTRA OPTIA APHERESIS SYSTEM
CARIDIANBCT, INC.
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