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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 K131202
Device Name MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X
Applicant
Dialysis Medical Solutions, LLC
21 E. State St., Suite 1700
Columbus,  OH  43215
Applicant Contact COURTNEY J MILLER
Correspondent
Dialysis Medical Solutions, LLC
21 E. State St., Suite 1700
Columbus,  OH  43215
Correspondent Contact COURTNEY J MILLER
Regulation Number876.5820
Classification Product Code
KPO  
Date Received04/29/2013
Decision Date 04/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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