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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K121634
Models 2C6891, 2C6895 AND 1C8621, 2C8891 AND 1C8684, 2C8895
Device Name INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR
Original Applicant
BAXTER HEALTHCARE CORPORATION
25212 w. illinois route 120
round lake,  IL  60073
Original Contact nanette hedden
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/04/2012
Decision Date 06/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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