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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 K910934
Device Name FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM
Applicant
Baxter Healthcare Corp
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Applicant Contact BONNIE J SMITH
Correspondent
Baxter Healthcare Corp
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact BONNIE J SMITH
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/06/1991
Decision Date 06/24/1991
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
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