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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 K910793
Device Name RECONSTITUTION DEVICE
Original Applicant
BAXTER HEALTHCARE CORP.
route 120 and wilson rd.
round lake,  IL  60073
Original Contact ellen snyder
Regulation Number880.5440
Classification Product Code
LHI  
Date Received02/25/1991
Decision Date 03/21/1991
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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