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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Single Pass
510(k) Number K771875
Device Name ULTRAFILTRATION MONITOR 5M9034
Applicant
Travenol Laboratories, S.A.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Travenol Laboratories, S.A.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5820
Classification Product Code
FIL  
Date Received10/05/1977
Decision Date 11/30/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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