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510(k) K992209

CUSTODIOL by Dr. Franz Kohler Chemie GmbH — Product Code KDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1999
Date Received
June 30, 1999
Clearance Type
Traditional
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 Dr. Franz Kohler Chemie GmbH

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  • K043461 — CUSTODIOL (February 28, 2005)
  • K032794 — CUSTODIOL (April 5, 2004)
  • K020924 — CUSTODIOL HTK SOLUTION (January 6, 2003)

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