510(k) K053583 ยท HIH Hysteroscope (And Accessories)
OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL
| Applicant | Optivia Medical, LLC, Winston-Salem NC, US |
| Decision | Substantially Equivalent, Mar 31, 2006 |
| Received | Dec 23, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053583
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.