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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 K120443
Device Name NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE
Applicant
Baxter Healthcare Corporation - Renal Division
1620 Waukegan Rd.
Bldg. R
Mcgaw Park,  IL  60085
Applicant Contact NANETTE HEDDEN
Correspondent
Baxter Healthcare Corporation - Renal Division
1620 Waukegan Rd.
Bldg. R
Mcgaw Park,  IL  60085
Correspondent Contact NANETTE HEDDEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/14/2012
Decision Date 05/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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