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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 K830575
Device Name RENALIN (TENTATIVE
Applicant
Renal Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Renal Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5820
Classification Product Code
LIF  
Date Received02/23/1983
Decision Date 03/31/1983
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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