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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 K123874
Device Name INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
Applicant
Baxter Healthcare Corp
32650 N. Wilson Rd.
Round Lake,  IL  60073
Applicant Contact NANETTE HEDDEN
Correspondent
Baxter Healthcare Corp
32650 N. Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact NANETTE HEDDEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/17/2012
Decision Date 01/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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