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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 K153158
Device Name Solution Administration Sets with 0.2 Micron Filter
Applicant
Baxter Healthcare Corporation
32650 N. Wilson Rd.
Round Lake,  IL  60073
Applicant Contact GARY CHUMBIMUNE
Correspondent
Baxter Healthcare Corporation
32650 N. Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact GARY CHUMBIMUNE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/02/2015
Decision Date 12/28/2015
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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