AMSURE RED RUBBER URETHRAL CATHETER


Device Classification Name

catheter, ureteral, gastro-urology

510(k) Number K030293
Device Name AMSURE RED RUBBER URETHRAL 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
EYB  
Date Received 01/28/2003
Decision Date 02/04/2004
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