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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K003730
Device Name CHEMO-AIDE DISPENSING PIN
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
LHI  
Date Received12/04/2000
Decision Date 12/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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