510(k) K123888 ยท MSS Folders And Injectors, Intraocular Lens (Iol)
Z CARTRIDGE IOL DELIVERY SYSTEM
| Applicant | Aaren Scientific, Inc., Ontario CA, US |
| Decision | Substantially Equivalent, Apr 15, 2013 |
| Received | Dec 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123888
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2017 | Aaren Scientific Inc. AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA.
Used to fold and insert the fir Terminated |
MSS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.