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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 K843014
Device Name FRESENIUS HAEMODIALYSIS A2008
Applicant
Seratronics, Inc.
4090 Pike Ln.
Concord,  CA  94520
Applicant Contact BEN J LIPPS
Correspondent
Seratronics, Inc.
4090 Pike Ln.
Concord,  CA  94520
Correspondent Contact BEN J LIPPS
Regulation Number876.5860
Classification Product Code
KDI  
Date Received07/31/1984
Decision Date 10/18/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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