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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 K012547
Device Name HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION
Applicant
Di-Chem, Inc.
12297 Ensign Ave. N.
Champlin,  MN  55316
Applicant Contact KEITH A BUCHHOLZ
Correspondent
Di-Chem, Inc.
12297 Ensign Ave. N.
Champlin,  MN  55316
Correspondent Contact KEITH A BUCHHOLZ
Regulation Number876.5820
Classification Product Code
KPO  
Date Received08/07/2001
Decision Date 01/18/2002
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
Recalls CDRH Recalls
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