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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 K915522
Device Name FLO-GARD(R) 6201
Original Applicant
route 120 and wilson rd.
round lake,  IL  60073
Original Contact patricia s barsanti
Regulation Number880.5725
Classification Product Code
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
Recalls CDRH Recalls