OPTION-VF URINARY CATHETER, FV14218


Device Classification Name

catheter, retention type, balloon

510(k) Number K023090
Device Name OPTION-VF URINARY CATHETER, FV14218
Original Applicant
OPTICON MEDICAL, INC.
7001 post rd., suite 100
dublin, 
OH 
43016

Original Contact glenn d brunner
Regulation Number 876.5130
Classification Product Code
EZL  
Date Received 09/17/2002
Decision Date 03/19/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No