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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 K891289
Device Name FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP
Applicant
BAXTER HEALTHCARE CORP.
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073
Applicant Contact DENNIS OCWIEJA
Correspondent
BAXTER HEALTHCARE CORP.
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073
Correspondent Contact DENNIS OCWIEJA
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/10/1989
Decision Date 02/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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