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510(k) K080432

MAPERSOL by Preservation Solutions, Inc. — Product Code KDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2008
Date Received
February 19, 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)
  • K083453 — COSTORSOL (January 21, 2009)
  • K073693 — COSTORSOL (July 3, 2008)
  • K022826 — CLEAR-IT ANTI-FOG, MODEL PS003 (October 9, 2002)

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