BICARD MIXING SYSTEM


Device Classification Name

tank, holding, dialysis

510(k) Number K030366
Device Name BICARD MIXING SYSTEM
Applicant
DIALYSIS SYSTEMS, INC.
2003 blair blvd.
nashville, 
TN 
37212

Applicant Contact mark vesligaj
Correspondent
DIALYSIS SYSTEMS, INC.
2003 blair blvd.
nashville, 
TN 
37212

Correspodent Contact mark vesligaj
Regulation Number 876.5820
Classification Product Code
FIN  
Date Received 02/04/2003
Decision Date 04/19/2004
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