KPS-I, THE KIDNEY PERFUSION SOLUTION— 510(k) K013575

Name: FDA 510(k) clearance K013575
Creator: U.S. Food and Drug Administration
Published: 2002-01-25

Substantially Equivalent

Organ Recovery Systems, Inc.

FDA 510(k) clearance K013575 for KPS-I, THE KIDNEY PERFUSION SOLUTION, Substantially Equivalent on 2002-01-25. Applicant: Organ Recovery Systems, Inc.. Device class: 2.

Clearance details

Applicant: Organ Recovery Systems, Inc.
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2001-10-29
Decision date: 2002-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charleston, SC, US

Download summary PDF View on FDA.gov ↗

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