The following data is part of a premarket notification filed by Rayner Intraocular Lenses Ltd. with the FDA for Rayner Small Incision Single Use Soft Tipped Injector, Model R-inj-04/18.
| Device ID | K091507 |
| 510k Number | K091507 |
| Device Name: | RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | RAYNER INTRAOCULAR LENSES LTD. SACKVILLE RD. Hove, East Sussex, GB Bn3 7an |
| Contact | Roynan H Kernaghan |
| Correspondent | Roynan H Kernaghan RAYNER INTRAOCULAR LENSES LTD. SACKVILLE RD. Hove, East Sussex, GB Bn3 7an |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-21 |
| Decision Date | 2009-12-04 |
| Summary: | summary |