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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 K121634
Device Name INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR
Applicant
Baxter Healthcare Corporation
25212 W. Illinois
Route 120
Round Lake,  IL  60073
Applicant Contact NANETTE HEDDEN
Correspondent
Baxter Healthcare Corporation
25212 W. Illinois
Route 120
Round Lake,  IL  60073
Correspondent Contact NANETTE HEDDEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/04/2012
Decision Date 06/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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