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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