510(k) K153698 ยท ODB Endoscopic Contamination Prevention Sheath
LumenR Tissue Retractor System
| Applicant | Lumenr, LLC, Matawan NJ, US |
| Decision | Substantially Equivalent, Apr 19, 2016 |
| Received | Dec 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153698
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.