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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 K904946
Device Name HAEMODIALYSIS CONCENTRATE
Applicant
BDH, INC.
350 EVANS AVE.
TORONTO, ONTARIO,  CA M8Z 1K5
Applicant Contact ALTHEA R LAWRENCE
Correspondent
BDH, INC.
350 EVANS AVE.
TORONTO, ONTARIO,  CA M8Z 1K5
Correspondent Contact ALTHEA R LAWRENCE
Regulation Number876.5820
Classification Product Code
KPO  
Date Received11/01/1990
Decision Date 04/09/1991
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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