MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION— 510(k) K022391

Name: FDA 510(k) clearance K022391
Creator: U.S. Food and Drug Administration
Published: 2002-10-21

Substantially Equivalent

Organ Recovery Systems, Inc.

FDA 510(k) clearance K022391 for MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION, Substantially Equivalent on 2002-10-21. 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: 2002-07-23
Decision date: 2002-10-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Charleston, SC, US

Download summary PDF View on FDA.gov ↗

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