VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000


Device Classification Name

catheter, urethrographic, male

510(k) Number K023019
Device Name VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
Original Applicant
VOMED VOLZER MEDIZINTECHNIK GMBH & CO.
152b bridge st.
hot springs, 
NC 
28743

Original Contact dagmar maser
Regulation Number 876.5130
Classification Product Code
FGI  
Date Received 09/11/2002
Decision Date 12/10/2002
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