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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
510(k) Number K891921
Device Name BICARBONATE CONCENTRATE POWDER
Applicant
HAEMOLYTE, INC.
1114 CLINTON AVE. P.O. BOX
120791
NASHVILLE,  TN  37212 -0791
Applicant Contact MELTON, D.PH
Correspondent
HAEMOLYTE, INC.
1114 CLINTON AVE. P.O. BOX
120791
NASHVILLE,  TN  37212 -0791
Correspondent Contact MELTON, D.PH
Regulation Number876.5820
Classification Product Code
KPO  
Date Received03/27/1989
Decision Date 04/17/1989
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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