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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, i.v. fluid transfer
510(k) Number K042410
Device Name BAXJECT II
Original Applicant
one baxter way
westlake village,  CA  91362
Original Contact ron lagerquist
Regulation Number880.5440
Classification Product Code
Date Received09/07/2004
Decision Date 10/08/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No