HEMODIALYSIS TUBING SETS


information about

Device Classification Name

protector, transducer, dialysis

510(k) Number K001971
Device Name HEMODIALYSIS TUBING SETS
Original Applicant
OFI BIOMEDICA S.P.A.
49 plain st.
north attleboro, 
MA 
02760

Original Contact mary mcnamara-cullinane
Regulation Number 876.5820
Classification Product Code
FIB  
Date Received 06/28/2000
Decision Date 05/24/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No