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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 K003225
Device Name SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
Applicant
BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE,  IL  60073
Applicant Contact MARY ELLEN SNYDER
Correspondent
BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE,  IL  60073
Correspondent Contact MARY ELLEN SNYDER
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FMF  
Date Received10/16/2000
Decision Date 10/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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