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510(k) K081997

PERFADEX WITH THAM by Vitrolife Sweden AB — Product Code MSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2008
Date Received
July 14, 2008
Clearance Type
Special
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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