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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 K860296
Device Name HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES
Original Applicant
PHYSICIANS SURGEONS PURCHASING GROUP
8927 south vermont ave.
los angeles,  CA  90044
Original Contact mack macdonald
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
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