510(k) DEN140030 ยท OVB Hydrogel Spacer
SpaceOAR System
| Applicant | Augmenix, Inc., Waltham MA, US |
| Decision | Unknown, Apr 1, 2015 |
| Received | Oct 1, 2014 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN140030
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.