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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 K984381
Device Name BURETROL SOLUTION SETS
Applicant
BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE,  IL  60073
Applicant Contact JUDY KANNENBERG
Correspondent
BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE,  IL  60073
Correspondent Contact JUDY KANNENBERG
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/08/1998
Decision Date 02/19/1999
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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