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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 K813403
Device Name FLO-GARD 8000 INFUSION PUMP SYSTEM
Applicant
TRAVENOL LABORATORIES, S.A.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TRAVENOL LABORATORIES, S.A.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/07/1981
Decision Date 12/31/1981
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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