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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 K090255
Device Name BLOOD TUBING SETS (STERILE FLUID PATH)
Applicant
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST., 5TH FLOOR
LAWRENCE,  MA  01843
Applicant Contact MICHAEL DOYLE
Correspondent
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST., 5TH FLOOR
LAWRENCE,  MA  01843
Correspondent Contact MICHAEL DOYLE
Regulation Number876.5820
Classification Product Code
FJK  
Subsequent Product Code
KOC  
Date Received02/02/2009
Decision Date 02/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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