OPHTACATH KIT

Lacrimal Stents And Intubation Sets

FRANCE CHIRURGAE INSTRUMENTATION

The following data is part of a premarket notification filed by France Chirurgae Instrumentation with the FDA for Ophtacath Kit.

Pre-market Notification Details

Device IDK123831
510k NumberK123831
Device Name:OPHTACATH KIT
ClassificationLacrimal Stents And Intubation Sets
Applicant FRANCE CHIRURGAE INSTRUMENTATION 3308 JEFFERSON AVE UPPER LEVEL Cincinnati,  OH  45220
ContactBarbara S Fant
CorrespondentBarbara S Fant
FRANCE CHIRURGAE INSTRUMENTATION 3308 JEFFERSON AVE UPPER LEVEL Cincinnati,  OH  45220
Product CodeOKS  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-12
Decision Date2013-07-29
Summary:summary

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