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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 K873887
Device Name MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.
Applicant
W.R. Grace & Co.-Conn.
17 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact JAMES M DELANEY
Correspondent
W.R. Grace & Co.-Conn.
17 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact JAMES M DELANEY
Regulation Number876.5860
Classification Product Code
KDI  
Date Received09/23/1987
Decision Date 12/09/1987
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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