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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K961225
Device Name CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
Original Applicant
BAXTER HEALTHCARE CORP.
route 120 and wilson rd.
round lake,  IL  60073
Original Contact mary ellen snyder
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/29/1996
Decision Date 06/21/1996
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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