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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
Applicant
Baxter Healthcare Corp
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Applicant Contact DENNIS OCWIEJA
Correspondent
Baxter Healthcare Corp
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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