FDA 510(k) Application Details - K111174

Device Classification Name Subsystem, Proportioning

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510(K) Number K111174
Device Name Subsystem, Proportioning
Applicant NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST., 5TH FLOOR
LAWRENCE, MA 01843 US
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Contact MARY LOU STROUMBOS
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Regulation Number 876.5820

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Classification Product Code FKR
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Date Received 04/27/2011
Decision Date 09/19/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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