LacriJet®

Lacrimal Stents And Intubation Sets

FCI (France Chirurgie Instrumentation) SAS

The following data is part of a premarket notification filed by Fci (france Chirurgie Instrumentation) Sas with the FDA for Lacrijet®.

Pre-market Notification Details

Device IDK201606
510k NumberK201606
Device Name:LacriJet®
ClassificationLacrimal Stents And Intubation Sets
Applicant FCI (France Chirurgie Instrumentation) SAS 20-22 Rue Louis Armand Paris,  FR 75015
ContactThierry Fetick
CorrespondentBarbara S. Fant
Clinical Research Consultants, Inc. 3308 Jefferson Avenue, Upper Level Cincinnati,  OH  45220
Product CodeOKS  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-15
Decision Date2020-12-18

Trademark Results [LacriJet]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LACRIJET
LACRIJET
79116040 4315383 Live/Registered
FRANCE CHIRURGIE INSTRUMENTATION SAS
2012-06-29

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