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 ID | K201606 |
| 510k Number | K201606 |
| Device Name: | LacriJet® |
| 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 | 2020-06-15 |
| Decision Date | 2020-12-18 |
Trademark Results [LacriJet]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LACRIJET 79116040 4315383 Live/Registered |
FRANCE CHIRURGIE INSTRUMENTATION SAS 2012-06-29 |
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