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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 (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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