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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Number K861776
Device Name HIGH EFFICIENCY HEMODIALYSIS SYSTEM
Applicant
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Applicant Contact JULIA A MEYER
Correspondent
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Correspondent Contact JULIA A MEYER
Regulation Number876.5860
Classification Product Code
KDI  
Date Received05/08/1986
Decision Date 06/19/1986
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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