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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 K893716
Device Name VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000
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 Number880.5440
Classification Product Code
FPA  
Date Received05/18/1989
Decision Date 09/18/1989
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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