The following data is part of a premarket notification filed by Kaneka Pharma America Llc with the FDA for Lacriflow Cl.
| Device ID | K170247 |
| 510k Number | K170247 |
| Device Name: | Lacriflow CL |
| Classification | Lacrimal Stents And Intubation Sets |
| Applicant | KANEKA PHARMA AMERICA LLC 546 FIFTH AVE., 21ST FLOOR New York, NY 10036 |
| Contact | Masaaki Fukunishi |
| Correspondent | Izumi Maruo MIC International 4-1-17 Hongo Bunkyo-ku, JP 113-0033 |
| Product Code | OKS |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-27 |
| Decision Date | 2017-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14540778171395 | K170247 | 000 |
| 04540778171381 | K170247 | 000 |