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FDA 510(k) Applications Submitted by Tyler Senjem
FDA 510(k) Number
Submission Date
Device Name
Applicant
K183511
12/18/2018
Affinity PixieÖ Oxygenator with BalanceÖ Biosurface (Model BBP211), Affinity PixieÖ Oxygenator and Cardiotomy/Venous Reservoir with BalanceÖ Biosurface (Model BBP241), Affinity PixieÖ Oxygenator with CortivaÖ BioActive Surface (Model CBP211), Affinity Pix
Medtronic Inc
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