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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 K893742
Device Name FILTRAL TM 20 HEMODIALYZER/FILTER
Applicant
Hospal Medical Corp.
460 Mclaws Cir.
Suite 200
Williamsburg,  VA  23185
Applicant Contact JO LANG
Correspondent
Hospal Medical Corp.
460 Mclaws Cir.
Suite 200
Williamsburg,  VA  23185
Correspondent Contact JO LANG
Regulation Number876.5860
Classification Product Code
KDI  
Date Received05/17/1989
Decision Date 07/24/1989
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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