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510(k) K123874

INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S by Baxter Healthcare Corp — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2013
Date Received
December 17, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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