510(k) K120912 ยท HQC Unit, Phacofragmentation
INFINITI(R) VISION SYSTEM
| Applicant | Alcon Manufacturing, Ltd., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 15, 2012 |
| Received | Mar 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120912
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2014 | Alcon Research, Ltd. INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082, 8065741083,
8065741085, 8065741087, 8065741088, 8065741089, 8 Terminated |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.