510(k) K082871 ยท MSS Folders And Injectors, Intraocular Lens (Iol)
XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
| Applicant | Sis Ltd., Surgical Instrument Systems, Greenwood Village CO, US |
| Decision | Substantially Equivalent, Jul 9, 2009 |
| Received | Sep 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082871
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.