510(k) K063155 ยท KYB Lens, Guide, Intraocular
MONARCH III IOL DELIVERY SYSTEM
| Applicant | Alcon Manufacturing, Ltd., Fort Worth TX, US |
| Decision | Substantially Equivalent, Mar 27, 2007 |
| Received | Oct 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063155
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Alcon Research LLC Brand Name: Alcon
Product Name: Monarch III D Delivery Cartridge
Model/Catalog Number: 8065977763
Product Description: Monarch III D delivery cartridge
Lens Guide, Intraocular
Component: N/A Open, Classified |
KYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.