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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 K172544
Device Name IV Fat Emulsion Administration Sets
Applicant
Baxter Healthcare Corporation
32650 N. Wilson Road
Round Lake,  IL  60073
Applicant Contact Jill M. Laack
Correspondent
Baxter Healthcare Corporation
32650 N. Wilson Road
Round Lake,  IL  60073
Correspondent Contact Jill M. Laack
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/23/2017
Decision Date 09/22/2017
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
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