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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, Capillary, Hollow Fiber
510(k) Number K874872
Device Name FRESENIUS HEMOFLOW F3, F4, F5, F7
Applicant
Seratronics, Inc.
4090 Pike Ln.
Concord,  CA  94520
Applicant Contact THOMAS E CANE
Correspondent
Seratronics, Inc.
4090 Pike Ln.
Concord,  CA  94520
Correspondent Contact THOMAS E CANE
Regulation Number876.5820
Classification Product Code
FJI  
Date Received11/27/1987
Decision Date 02/19/1988
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
Recalls CDRH Recalls
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