510(k) K073678 ยท DZI Drill, Bone, Powered
VARIOSURG
| Applicant | Nakanishi, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Jul 10, 2008 |
| Received | Dec 28, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073678
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2016 | Nakanishi Inc. Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light)
The intended use of the tips is based on the parent device. For the VarioSurg, in addition Terminated |
ELC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.