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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 K130511
Device Name CITRISOL ACID CONCENTRATE
Applicant
DIASOL, INC.
1110 Arroyo St
San Fernando,  CA  91340
Applicant Contact MONICA ABELES
Correspondent
DIASOL, INC.
1110 Arroyo St
San Fernando,  CA  91340
Correspondent Contact MONICA ABELES
Regulation Number876.5820
Classification Product Code
KPO  
Date Received02/27/2013
Decision Date 02/10/2014
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
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