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510(k) K991594

CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS by Sangstat Medical Corp. — Product Code MSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1999
Date Received
May 7, 1999
Clearance Type
Traditional
Expedited Review
Yes
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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