The following data is part of a premarket notification filed by France Chirurgae Instrumentation with the FDA for Ophtacath Kit.
| Device ID | K123831 |
| 510k Number | K123831 |
| Device Name: | OPHTACATH KIT |
| Classification | Lacrimal Stents And Intubation Sets |
| Applicant | FRANCE CHIRURGAE INSTRUMENTATION 3308 JEFFERSON AVE UPPER LEVEL Cincinnati, OH 45220 |
| Contact | Barbara S Fant |
| Correspondent | Barbara S Fant FRANCE CHIRURGAE INSTRUMENTATION 3308 JEFFERSON AVE 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 | 2012-12-12 |
| Decision Date | 2013-07-29 |
| Summary: | summary |