TORAYSULFONE DIALYZER, BS-L SERIES


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K030050
Device Name TORAYSULFONE DIALYZER, BS-L SERIES
Original Applicant
TORAY INDUSTRIES (AMERICA), INC.
540 college st.
bellaire, 
TX 
77401 -5010

Original Contact lisa s jones
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 01/06/2003
Decision Date 09/29/2003
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