The following data is part of a premarket notification filed by Fci Sas (france Chirurgie Instrumentation) with the FDA for Self-retaining Bicanaliculus Intubaton Set Ii.
| Device ID | K130375 |
| 510k Number | K130375 |
| Device Name: | SELF-RETAINING BICANALICULUS INTUBATON SET II |
| Classification | Lacrimal Stents And Intubation Sets |
| Applicant | FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) 3308 JEFFERSON AVENUE UPPER LEVEL Cincinnati, OH 45220 |
| Contact | Barbara S Fant |
| Correspondent | Barbara S Fant FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) 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 | 2013-02-14 |
| Decision Date | 2013-12-04 |
| Summary: | summary |