PERFADEX AND PERFADEX WITH THAM— 510(k) K091989

Name: FDA 510(k) clearance K091989
Creator: U.S. Food and Drug Administration
Published: 2010-10-01

Substantially Equivalent

Xvivo Perfusion AB

FDA 510(k) clearance K091989 for PERFADEX AND PERFADEX WITH THAM, Substantially Equivalent on 2010-10-01. Applicant: Xvivo Perfusion AB. Device class: 2.

Clearance details

Applicant: Xvivo Perfusion AB
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2009-07-02
Decision date: 2010-10-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Gutengurg, SE

Download summary PDF View on FDA.gov ↗

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