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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer Reprocessing System
510(k) Number K874573
Device Name FRESENIUS PURISTERIL 340 (TM)
Applicant
Seratronics, Inc.
4090 Pike Ln.
Concord,  CA  94520
Applicant Contact SCOTT N WALKER
Correspondent
Seratronics, Inc.
4090 Pike Ln.
Concord,  CA  94520
Correspondent Contact SCOTT N WALKER
Regulation Number876.5820
Classification Product Code
LIF  
Date Received11/05/1987
Decision Date 04/25/1988
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
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