TORAYSULFONE DIALYZER


definition

Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K002512
Device Name TORAYSULFONE DIALYZER
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 08/15/2000
Decision Date 10/15/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls