The following data is part of a premarket notification filed by Rayner Intraocular Lenses Ltd. with the FDA for Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft Tipped Small Incision Disposable Injector.
| Device ID | K132002 |
| 510k Number | K132002 |
| Device Name: | SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | RAYNER INTRAOCULAR LENSES LTD. 1-2 SACKVILLE ROAD Hove, East Sussex, GB Bn3 7an |
| Contact | Juliette E Cook |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-07-01 |
| Decision Date | 2014-03-27 |
| Summary: | summary |