510(k) K001157 ยท KYB Lens, Guide, Intraocular
MONARCH II IOL DELIVERY SYSTEM
| Applicant | Alcon Research, Ltd., Fort Worth TX, US |
| Decision | Substantially Equivalent, Jun 27, 2000 |
| Received | Apr 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001157
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2008 | Alcon Laboratories, Inc MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Worth, Texas 76134 USA***for AcrySof IOLs* Terminated |
KYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.