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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 K171750
Device Name Citric Complete Dry Citric Acid (45X)
Applicant
Dimesol USA, LLC
509 Fishing Creek Road
Lewisberry,  PA  17339
Applicant Contact Marlene Van Dyke
Correspondent
McNees Wallace & Nurick LLC
21 East State Street, Suite 1700
Columbus,  OH  43215
Correspondent Contact David M. Marcus
Regulation Number876.5820
Classification Product Code
KPO  
Date Received06/13/2017
Decision Date 03/06/2018
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
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