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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 K925126
Device Name INTERLINK(TM) INJECTION SITE
Original Applicant
BAXTER HEALTHCARE CORP.
route 120 and wilson rd.
round lake,  IL  60073
Original Contact marcia marconi
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/13/1992
Decision Date 06/18/1993
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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