The following data is part of a premarket notification filed by Rayner Intraocular Lenses Ltd. with the FDA for Raysert Plus Injector, Single Use Soft Tipped Disposable Injector.
| Device ID | K143307 |
| 510k Number | K143307 |
| Device Name: | RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | RAYNER INTRAOCULAR LENSES LTD. 1-2 SACKVILLE TRADING ESTATE, SACKVILLE ROAD Hove, GB Bn3 7an |
| Contact | Juliette Cook |
| Correspondent | Juliette Cook RAYNER INTRAOCULAR LENSES LTD. 1-2 SACKVILLE TRADING ESTATE, SACKVILLE ROAD Hove, GB Bn3 7an |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-18 |
| Decision Date | 2014-12-18 |
| Summary: | summary |