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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 K801825
Device Name RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D.
Applicant
Renal Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Renal Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5820
Classification Product Code
FJI  
Date Received07/31/1980
Decision Date 09/26/1980
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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