510(k) K143738 ยท LRC Instrument, Ent Manual Surgical
DSS Sinusplasty Balloon Catheter
| Applicant | Intuit Medical Products, LLC, Sugar Hill GA, US |
| Decision | Substantially Equivalent, Aug 27, 2015 |
| Received | Dec 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143738
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.