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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 K890205
Device Name AUTOMIX COMPOUNDER Y - ADAPTOR SET
Applicant
Stedim, Inc.
3667 Perada Dr.
Walnut Creek,  CA  94598
Applicant Contact BRYAN L KRAUSE
Correspondent
Stedim, Inc.
3667 Perada Dr.
Walnut Creek,  CA  94598
Correspondent Contact BRYAN L KRAUSE
Regulation Number880.5440
Classification Product Code
LHI  
Date Received01/18/1989
Decision Date 10/27/1989
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
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