510(k) K122503 ยท NDN Cement, Bone, Vertebroplasty
PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
| Applicant | Neuro Therm, Inc., Ashland MA, US |
| Decision | Substantially Equivalent, Jun 25, 2013 |
| Received | Aug 16, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122503
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.