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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 K042936
Device Name SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE
Applicant
BAXTER HEALTHCARE CORP.
route 120 and wilson rd.
round lake,  IL  60073
Contact nanette hedden
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/25/2004
Decision Date 11/26/2004
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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