AMSURE FOLEY CATHETER


Device Classification Name

catheter, retention type, balloon

510(k) Number K030120
Device Name AMSURE FOLEY CATHETER
Original Applicant
AMSINO INTERNATIONAL, INC.
4501 brickell privado st.
ontario, 
CA 
91761

Original Contact ching ching seah
Regulation Number 876.5130
Classification Product Code
EZL  
Date Received 01/13/2003
Decision Date 10/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No