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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, Capillary, Hollow Fiber
510(k) Number K870169
Device Name CAPILLARY FLOW DIALYZERS
Applicant
Travenol Laboratories, S.A.
Wilson Rd. At Rte. 120
P.O. Box 490
Round Lake,  IL  60073
Applicant Contact ROBERT L WILKINSON
Correspondent
Travenol Laboratories, S.A.
Wilson Rd. At Rte. 120
P.O. Box 490
Round Lake,  IL  60073
Correspondent Contact ROBERT L WILKINSON
Regulation Number876.5820
Classification Product Code
FJI  
Date Received01/14/1987
Decision Date 04/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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