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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 K093379
Device Name TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM
Applicant
Bl Healthcare, Inc.
33 Commercial St., Suite #3
Foxboro,  MA  02035
Applicant Contact MICHAEL MATHUR
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact JAY Y KOGOMA
Regulation Number876.5860
Classification Product Code
KDI  
Date Received10/29/2009
Decision Date 02/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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