510(k) K130736 ยท LRC Instrument, Ent Manual Surgical
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
| Applicant | Helix Medical, LLC, Carpinteria CA, US |
| Decision | Substantially Equivalent, Dec 17, 2013 |
| Received | Mar 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130736
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.