BLOOD TUBING SETS (STERILE FLUID PATH)

Set, Tubing, Blood, With And Without Anti-regurgitation Valve

NXSTAGE MEDICAL, INC.

The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Blood Tubing Sets (sterile Fluid Path).

Pre-market Notification Details

Device IDK080807
510k NumberK080807
Device Name:BLOOD TUBING SETS (STERILE FLUID PATH)
ClassificationSet, Tubing, Blood, With And Without Anti-regurgitation Valve
Applicant NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence,  MA  01843
ContactMichael Doyle
CorrespondentMichael Doyle
NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence,  MA  01843
Product CodeFJK  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-21
Decision Date2008-07-18
Summary:summary

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