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510(k) K083453

COSTORSOL by Preservation Solutions, Inc. — Product Code KDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2009
Date Received
November 21, 2008
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 Preservation Solutions, Inc.

  • K151728 — CoStorSol plus G (September 18, 2015)
  • K091245 — COSTORSOL (June 17, 2009)
  • K080432 — MAPERSOL (August 8, 2008)
  • K073693 — COSTORSOL (July 3, 2008)
  • K022826 — CLEAR-IT ANTI-FOG, MODEL PS003 (October 9, 2002)

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