The following data is part of a premarket notification filed by Tribofilm Research, Inc. with the FDA for Staclear Syringe.
| Device ID | K200242 |
| 510k Number | K200242 |
| Device Name: | StaClear Syringe |
| Classification | Ophthalmic Syringe |
| Applicant | TriboFilm Research, Inc. 625 Hutton Street Raleigh, NC 27606 |
| Contact | Jackson Thornton |
| Correspondent | Beryl St. Jeanne NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426 |
| Product Code | QLY |
| Subsequent Product Code | FMF |
| Subsequent Product Code | FMI |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-31 |
| Decision Date | 2020-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B994SC2501 | K200242 | 000 |
| B994SC250LS2 | K200242 | 000 |
| B994SC250AN0 | K200242 | 000 |
| B994SC250LL0 | K200242 | 000 |