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510(k) K022730

PERFADEX SOLUTION FOR LUNG PRESERVATION by Vitrolife AB — Product Code MSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2003
Date Received
August 16, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System And Accessories, Isolated Heart, Transport And Preservation
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

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