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510(k) K000881

PERFADEX SOLUTION FOR ORGAN PRESERVATION by Vitrolife Sweden AB — Product Code MSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2001
Date Received
March 20, 2000
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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