510(k) K111446 ยท HQC Unit, Phacofragmentation
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
| Applicant | Abbott Medical Optics, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Dec 21, 2011 |
| Received | May 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111446
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2013 | Abbott Medical Optics, Inc. Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery. Terminated |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.