The following data is part of a premarket notification filed by Fci Sas (france Chirurgie Instrumentation) with the FDA for Masterka 40 Masterka 35 Masterka 30.
| Device ID | K113536 |
| 510k Number | K113536 |
| Device Name: | MASTERKA 40 MASTERKA 35 MASTERKA 30 |
| Classification | Lacrimal Stents And Intubation Sets |
| Applicant | FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) 3308 JEFFERSON AVENUE UPPER LEVEL Cincinnati, OH 45220 |
| Contact | Barbara Frant |
| Correspondent | Barbara Frant 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 | 2011-11-30 |
| Decision Date | 2012-08-03 |
| Summary: | summary |