PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY


Device Classification Name

dialysate concentrate for hemodialysis (liquid or powder)

510(k) Number K072908
Device Name PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY
Applicant
GAMBRO RENAL PRODUCTS
1845 mason ave.
daytona beach, 
FL 
32117 -5102

Applicant Contact fei law
Correspondent
GAMBRO RENAL PRODUCTS
1845 mason ave.
daytona beach, 
FL 
32117 -5102

Correspodent Contact fei law
Regulation Number 876.5820
Classification Product Code
KPO  
Date Received 10/12/2007
Decision Date 02/04/2008
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