510(k) K060366 ยท HQC Unit, Phacofragmentation
THE AMO OPHTHALMIC SURGICAL SYSTEM
| Applicant | Advanced Medical Optics, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Apr 7, 2006 |
| Received | Feb 13, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K060366
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2008 | Advanced Medical Optics, Inc. Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification System, Product Number NGP680300. The device is a modular ophthalmic microsurgical system that facilitates both anterior se Terminated |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.