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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Number K233557
Device Name HemoCare Hemodialysis System
Applicant
Deka Research and Development
340 Commercial Street
Manchester,  NH  03101
Applicant Contact Paul Smolenski
Correspondent
Deka Research and Development
340 Commercial Street
Manchester,  NH  03101
Correspondent Contact Paul Smolenski
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Codes
FIP   FJK  
Date Received11/06/2023
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 Yes
Predetermined Change
Control Plan Authorized		 No
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