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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
Device Name CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS
Applicant
BAXTER HEALTHCARE CORPORATION
1620 WAUKEGAN RD.
MCGAW PARK,  IL  60085
Applicant Contact NANETTE HEDDEN
Correspondent
BAXTER HEALTHCARE CORPORATION
1620 WAUKEGAN RD.
MCGAW PARK,  IL  60085
Correspondent Contact NANETTE HEDDEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/03/2011
Decision Date 10/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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