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FDA 510(k) Applications Submitted by Colleen Powell
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190282
02/11/2019
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
Spectrum Medical Ltd
K210669
03/05/2021
Quantum Mini Ventilation Module
Spectrum Medical Ltd.
K181923
07/18/2018
Quantum Workstation 12.1
Spectrum Medical Ltd
K212657
08/23/2021
Quantum Heater-Cooler
Spectrum Medical Ltd.
K202557
09/03/2020
Quantum Workstation 12 Elite
Spectrum Medical Ltd
K202733
09/18/2020
Quantum Ventilation Module
Spectrum Medical Ltd
K192838
10/03/2019
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
Spectrum Medical Ltd
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