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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K915523
Device Name FLO-GARD(R) 6301
Applicant
BAXTER HEALTHCARE CORP.
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073
Applicant Contact PATRICIA S BARSANTI
Correspondent
BAXTER HEALTHCARE CORP.
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073
Correspondent Contact PATRICIA S BARSANTI
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/10/1991
Decision Date 02/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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