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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Infusion Line
510(k) Number K865029
Device Name CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
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 Number880.5440
Classification Product Code
FPB  
Date Received12/23/1986
Decision Date 04/17/1987
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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