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

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..

Clearance details

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

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