The following data is part of a premarket notification filed by Fci (france Chirurgie Instrumentation) Sas with the FDA for Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants.
| Device ID | K203569 |
| 510k Number | K203569 |
| Device Name: | Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants |
| Classification | Weights, Eyelid, Implantable |
| Applicant | FCI (France Chirurgie Instrumentation) SAS 20-22 Rue Louis Armand Paris, FR 75015 |
| Contact | Thierry Fetick |
| Correspondent | Dennis Hahn Clinical Research Consultants, Inc. 3308 Jefferson Avenue, Upper Level Cincinnati, OH 45220 |
| Product Code | NCB |
| CFR Regulation Number | 886.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-07 |
| Decision Date | 2021-06-11 |