510(k) K133115 ยท HQC Unit, Phacofragmentation
COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK
| Applicant | Abbott Medical Optics, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Feb 27, 2014 |
| Received | Sep 30, 2013 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K133115
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2023 | Johnson & Johnson Surgical Vision, Inc. Single-Use Packs, REF: OPO80 Open, Classified |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.