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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 K011269
Device Name LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR
Applicant
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST.
SUITE 501
S. LAWRENCE,  MA  01843
Applicant Contact KAREN ST. ONGE
Correspondent
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST.
SUITE 501
S. LAWRENCE,  MA  01843
Correspondent Contact KAREN ST. ONGE
Regulation Number876.5860
Classification Product Code
KDI  
Date Received04/26/2001
Decision Date 03/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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