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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 K941958
Device Name WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE
Applicant
Western Dialysis Supplies , Ltd.
117, 3016 10 Ave. NE
Calgary, Alberta,  CA T2A 6A3
Applicant Contact HARRIPAUL TULAN
Correspondent
Western Dialysis Supplies , Ltd.
117, 3016 10 Ave. NE
Calgary, Alberta,  CA T2A 6A3
Correspondent Contact HARRIPAUL TULAN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received04/22/1994
Decision Date 09/30/1994
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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