AMSURE URETHRAL CATHETERIZATION TRAY


Device Classification Name

tray, catheterization, sterile urethral, with or without catheter (kit)

510(k) Number K030712
Device Name AMSURE URETHRAL CATHETERIZATION TRAY
Applicant
AMSINO INTERNATIONAL, INC.
4501 brickell privado st.
ontario, 
CA 
91761

Applicant Contact ching ching seah
Correspondent
AMSINO INTERNATIONAL, INC.
4501 brickell privado st.
ontario, 
CA 
91761

Correspodent Contact ching ching seah
Regulation Number 876.5130
Classification Product Code
FCM  
Date Received 03/06/2003
Decision Date 05/23/2003
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