510(k) K131177 ยท KAR Irrigator, Sinus
SINUFLUSH LAVAGE SYSTEM
| Applicant | Hedgepath, LLC, Tampa FL, US |
| Decision | Substantially Equivalent, Sep 20, 2013 |
| Received | Apr 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131177
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.