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510(k) K022391

MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION by Organ Recovery Systems, Inc. — Product Code KDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2002
Date Received
July 23, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Perfusion, Kidney
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

Other clearances by Organ Recovery Systems, Inc.

  • K091656 — SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L (March 11, 2010)
  • K021362 — LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) (July 31, 2003)
  • K013575 — KPS-I, THE KIDNEY PERFUSION SOLUTION (January 25, 2002)

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