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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 K892262
Device Name FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M
Applicant
Fresenius USA, Inc.
4090 Pike Ln.
Concord,  CA  94520
Applicant Contact SCOTT N WALKER
Correspondent
Fresenius USA, Inc.
4090 Pike Ln.
Concord,  CA  94520
Correspondent Contact SCOTT N WALKER
Regulation Number876.5860
Classification Product Code
KDI  
Date Received04/05/1989
Decision Date 04/25/1989
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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