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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Single Patient
510(k) Number K813432
Device Name HEMODIALYSIS SYSTEM
Applicant
FHK
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
FHK
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5820
Classification Product Code
FKP  
Date Received12/08/1981
Decision Date 06/23/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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