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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 K894827
Device Name AUTOMIX 3+3 COMPOUNDER
Original Applicant
BAXTER HEALTHCARE CORP.
route 120 and wilson rd.
round lake,  IL  60073
Original Contact dennis ocwieja
Regulation Number880.5440
Classification Product Code
LHI  
Date Received07/31/1989
Decision Date 10/06/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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