OMNI-DL SYSTEM


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K080650
Device Name OMNI-DL SYSTEM
Applicant
TRANSVIVO INC.
3067 research drive
richmond, 
CA 
94806

Applicant Contact j. michael delmage
Correspondent
TRANSVIVO INC.
3067 research drive
richmond, 
CA 
94806

Correspodent Contact j. michael delmage
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 03/07/2008
Decision Date 11/26/2008
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