NXSTAGE SYSTEM ONE


Device Classification Name

system, dialysate delivery, sealed

510(k) Number K030470
Device Name NXSTAGE SYSTEM ONE
Applicant
NXSTAGE MEDICAL, INC.
439 south union st.
suite 501
lawrence, 
MA 
01843

Applicant Contact norma lemay
Regulation Number 876.5860
Classification Product Code
FII  
Date Received 02/12/2003
Decision Date 07/07/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No