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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
Applicant
PHYSICIANS SURGEONS PURCHASING GROUP
8927 SOUTH VERMONT AVE.
LOS ANGELES,  CA  90044
Applicant Contact MACK MACDONALD
Correspondent
PHYSICIANS SURGEONS PURCHASING GROUP
8927 SOUTH VERMONT AVE.
LOS ANGELES,  CA  90044
Correspondent 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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