OPTION-VF URINARY CATHETER, FV14218

Catheter, Retention Type, Balloon

OPTICON MEDICAL, INC.

The following data is part of a premarket notification filed by Opticon Medical, Inc. with the FDA for Option-vf Urinary Catheter, Fv14218.

Pre-market Notification Details

Device IDK023090
510k NumberK023090
Device Name:OPTION-VF URINARY CATHETER, FV14218
ClassificationCatheter, Retention Type, Balloon
Applicant OPTICON MEDICAL, INC. 7001 POST RD., SUITE 100 Dublin,  OH  43016
ContactGlenn D Brunner
CorrespondentGlenn D Brunner
OPTICON MEDICAL, INC. 7001 POST RD., SUITE 100 Dublin,  OH  43016
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-17
Decision Date2003-03-19
Summary:summary

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