LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT


Device Classification Name

accessories, blood circuit, hemodialysis

510(k) Number K081043
Device Name LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
Applicant
NXSTAGE MEDICAL, INC.
439 south union st., 5th floor
lawrence, 
MA 
01843

Applicant Contact mary lou stroumbos
Correspondent
NXSTAGE MEDICAL, INC.
439 south union st., 5th floor
lawrence, 
MA 
01843

Correspodent Contact mary lou stroumbos
Regulation Number 876.5820
Classification Product Code
KOC  
Date Received 04/14/2008
Decision Date 07/07/2008
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