510(k) K111593 ยท NDN Cement, Bone, Vertebroplasty
GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
| Applicant | Bm Korea Co., Ltd., Marietta GA, US |
| Decision | Substantially Equivalent, Nov 18, 2011 |
| Received | Jun 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111593
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.