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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K023090
Device Name OPTION-VF URINARY CATHETER, FV14218
Applicant
OPTICON MEDICAL, INC.
7001 POST RD., SUITE 100
DUBLIN,  OH  43016
Applicant Contact GLENN D BRUNNER
Correspondent
OPTICON MEDICAL, INC.
7001 POST RD., SUITE 100
DUBLIN,  OH  43016
Correspondent Contact GLENN D BRUNNER
Regulation Number876.5130
Classification Product Code
EZL  
Date Received09/17/2002
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
Recalls CDRH Recalls
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