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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lacrimal Stents And Intubation Sets
510(k) Number K201892
Device Name Ritleng®+ and Ritleng®+ PVP
Applicant
Fci (France Chirurgie Instrumentation) Sas
20-22 Rue Louis Armand
Paris,  FR 75015
Applicant Contact Thierry Fetick
Correspondent
Clinical Research Consultants, Inc.
3308 Jefferson Ave., Upper Level
Cincinnati,  OH  45220
Correspondent Contact Barbara S. Fant
Classification Product Code
OKS  
Date Received07/08/2020
Decision Date 03/11/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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