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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 K112893
Model 2N8399, 2N8378, 2N8377, 2N8374, 2N8371, 2H8401, 2C8425S
Device Name CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS
Original Applicant
BAXTER HEALTHCARE CORPORATION
1620 waukegan rd.
mcgaw park,  IL  60085
Original Contact nanette hedden
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/03/2011
Decision Date 10/18/2011
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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