NXSTAGE PREMIXED DIALYSATE


Device Classification Name

dialysate concentrate for hemodialysis (liquid or powder)

510(k) Number K022913
Device Name NXSTAGE PREMIXED DIALYSATE
Original Applicant
NXSTAGE MEDICAL, INC.
439 south union st.
suite 501
lawrence, 
MA 
01843

Original Contact norma lemay
Regulation Number 876.5820
Classification Product Code
KPO  
Date Received 09/03/2002
Decision Date 10/21/2002
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