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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 K121092
Device Name FLOWEASE [SUBCUTANEOUS] INFUSION SET
Applicant
BAXTER HEALTHCARE CORP.
ONE BAXTER WAY
WESTLAKE VILLAGE,  CA  91362
Applicant Contact NIEDRE M HECKMAN
Correspondent
BAXTER HEALTHCARE CORP.
ONE BAXTER WAY
WESTLAKE VILLAGE,  CA  91362
Correspondent Contact NIEDRE M HECKMAN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/10/2012
Decision Date 06/29/2012
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
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