510(k) K911808 ยท HQC Unit, Phacofragmentation
GEMINI OPHTHALMIC SURGERY SYSTEM
| Applicant | Alcon Laboratories, Fort Worth TX, US |
| Decision | Substantially Equivalent, Jun 25, 1991 |
| Received | Apr 23, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911808
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2015 | Alcon Research, Ltd. Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe wit Terminated |
HQC | None listed |
| May 26, 2009 | Alcon Laboratories, Inc Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134. Terminated |
NGY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.