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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 ROAD
ROUND LAKE,  IL  60073
Applicant Contact GARY CHUMBIMUNE
Correspondent
BAXTER HEALTHCARE CORPORATION
32650 N WILSON ROAD
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
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