FDA 510(k) K170826, Perfadex Plus, by Xvivo Perfusion AB
FDA 510(k) K170826, Perfadex Plus, by Xvivo Perfusion AB
Device Classification Name: System, Perfusion, Kidney
510(k) Number: K170826
Device Name: Perfadex Plus
Applicant: Xvivo Perfusion AB
Regulation Number: 876.588
Classification Product Code: KDN
Date Received: 2017-03-20
Decision Date: 2018-06-22
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: Gastroenterology/Urology
Total number of pages: 2,271
Fully redacted pages: 1,818
Content pages: 453
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