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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 K914580
Device Name DRS-4 DIALYZER REPROCESSING SYSTEM
Applicant
Seratronics, Inc.
4090 Pike Ln.
Concord,  CA  94520
Applicant Contact SCOTT WALKER
Correspondent
Seratronics, Inc.
4090 Pike Ln.
Concord,  CA  94520
Correspondent Contact SCOTT WALKER
Regulation Number876.5820
Classification Product Code
LIF  
Date Received10/16/1991
Decision Date 02/24/1992
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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