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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 K884626
Device Name MODIFIED SLIDING RECONSTITUTION DEVICE
Original Applicant
BAXTER HEALTHCARE CORP.
route 120 and wilson rd.
round lake,  IL  60073
Original Contact patricia s barsanti
Regulation Number880.5440
Classification Product Code
LHI  
Date Received11/07/1988
Decision Date 11/22/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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