510(k) DEN150028 ยท PMU Containment System, Laparoscopic Power Morcellation, With Instrument Port
PneumoLiner
| Applicant | Advanced Surgical Concepts, Ltd., Bray, IE |
| Decision | Unknown, Apr 7, 2016 |
| Received | Jun 19, 2015 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN150028
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.