510(k) K112134 ยท HIH Hysteroscope (And Accessories)
TRUCLEAR OPERATIVE HYSTEROSCOPE
| Applicant | Smith & Nephew, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Nov 22, 2011 |
| Received | Jul 27, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112134
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.