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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 K013655
Device Name NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100
Applicant
Nxstage Medical, Inc.
439 S. Union St. Suite 501
Lawrence,  MA  01843
Applicant Contact KAREN ST. ONGE
Correspondent
Nxstage Medical, Inc.
439 S. Union St. Suite 501
Lawrence,  MA  01843
Correspondent Contact KAREN ST. ONGE
Regulation Number876.5820
Classification Product Code
KPO  
Date Received11/06/2001
Decision Date 02/04/2002
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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