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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 K872767
Device Name FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER
Applicant
Hospal Medical Corp.
21 Northfield Ave.
Raritan Center
Edison,  NJ  08837
Applicant Contact CATHERINA MADORMO
Correspondent
Hospal Medical Corp.
21 Northfield Ave.
Raritan Center
Edison,  NJ  08837
Correspondent Contact CATHERINA MADORMO
Regulation Number876.5860
Classification Product Code
KDI  
Date Received07/14/1987
Decision Date 12/29/1987
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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