510(k) K961310 ยท HQC Unit, Phacofragmentation
STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)
| Applicant | Storz Instrument Co., St. Louis MO, US |
| Decision | Substantially Equivalent, Jun 27, 1996 |
| Received | Apr 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961310
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2010 | Bausch & Lomb Inc Bausch & Lomb Millennium Microsurgical System. Terminated |
NFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.