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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K140841
Device Name TABLO CARTRIDGE
Applicant
Home Dialysis Plus
257 Humboldt Ct.
Sunnyvale,  CA  94089
Applicant Contact NANCY GALLO
Correspondent
Home Dialysis Plus
257 Humboldt Ct.
Sunnyvale,  CA  94089
Correspondent Contact NANCY GALLO
Regulation Number876.5820
Classification Product Code
FJK  
Date Received04/02/2014
Decision Date 09/11/2014
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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