510(k) K133857 ยท HIB Speculum, Vaginal, Nonmetal
BRELLA-SPEC(TM) VAGINAL SPECULUM
| Applicant | Proa Medical, Inc., Redondo Beach CA, US |
| Decision | Substantially Equivalent, Apr 28, 2014 |
| Received | Dec 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133857
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.