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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 K870801
Device Name FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
Applicant
Travenol Laboratories, S.A.
Wilson Rd. At Rte. 120
P.O. Box 490
Round Lake,  IL  60073
Applicant Contact JULIA A MEYER
Correspondent
Travenol Laboratories, S.A.
Wilson Rd. At Rte. 120
P.O. Box 490
Round Lake,  IL  60073
Correspondent Contact JULIA A MEYER
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/27/1987
Decision Date 09/04/1987
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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