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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, Central Multiple Patient
510(k) Number K860297
Device Name HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES
Applicant
Renal Hygienics
18425 Burbank Blvd., Suite 411
Tarzana,  CA  91356
Applicant Contact ERIC KLUMPH
Correspondent
Renal Hygienics
18425 Burbank Blvd., Suite 411
Tarzana,  CA  91356
Correspondent Contact ERIC KLUMPH
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received01/28/1986
Decision Date 03/04/1986
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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