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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 K990507
Device Name ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER
Applicant
Althin Biopharm, Inc.
3885 Industrial Blvd.
Laval, Quebec,  CA H7L 4S3
Applicant Contact JEAN SAURIOL
Correspondent
Althin Biopharm, Inc.
3885 Industrial Blvd.
Laval, Quebec,  CA H7L 4S3
Correspondent Contact JEAN SAURIOL
Regulation Number876.5820
Classification Product Code
KPO  
Date Received02/18/1999
Decision Date 05/07/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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