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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 K160007
Device Name Paclitaxel Sets
Applicant
BAXTER HEALTHCARE CORPORATION
32650 N. WILSON ROAD
ROUND LAKE,  IL  60073
Applicant Contact Tiffany Lin
Correspondent
BAXTER HEALTHCARE CORPORATION
32650 N. WILSON ROAD
ROUND LAKE,  IL  60073
Correspondent Contact Tiffany Lin
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/04/2016
Decision Date 12/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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