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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 K852251
Device Name FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40
Applicant
Seratronics, Inc.
4090 Pike Ln.
Concord,  CA  94520
Applicant Contact LIPPS, PH.D.
Correspondent
Seratronics, Inc.
4090 Pike Ln.
Concord,  CA  94520
Correspondent Contact LIPPS, PH.D.
Regulation Number876.5860
Classification Product Code
KDI  
Date Received05/23/1985
Decision Date 07/25/1985
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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