The following data is part of a premarket notification filed by Fci (france Chirurgie Instrumentation) Sas with the FDA for Ritleng®+ And Ritleng®+ Pvp.
Device ID | K201892 |
510k Number | K201892 |
Device Name: | Ritleng®+ And Ritleng®+ PVP |
Classification | Lacrimal Stents And Intubation Sets |
Applicant | FCI (France Chirurgie Instrumentation) SAS 20-22 Rue Louis Armand Paris, FR 75015 |
Contact | Thierry Fetick |
Correspondent | Barbara S. Fant Clinical Research Consultants, Inc. 3308 Jefferson Avenue, Upper Level Cincinnati, OH 45220 |
Product Code | OKS |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-07-08 |
Decision Date | 2021-03-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RITLENG 79202503 5238908 Live/Registered |
FRANCE CHIRURGIE INSTRUMENTATION SAS 2016-10-25 |