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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 K910213
Device Name NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact FREDERICK GUSTAFSON
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact FREDERICK GUSTAFSON
Regulation Number880.5440
Classification Product Code
LHI  
Date Received01/10/1991
Decision Date 04/16/1991
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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