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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 K240920
Device Name HemoCare Bicarbonate Concentrate Set (BCS)
Applicant
Deka Research and Development
340 Commercial St.
Manchester,  NH  03101
Applicant Contact Paul Smolenski
Correspondent
Deka Research and Development
340 Commercial St.
Manchester,  NH  03101
Correspondent Contact Paul Smolenski
Regulation Number876.5820
Classification Product Code
KPO  
Date Received04/04/2024
Decision Date 07/12/2024
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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