510(k) K002828 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
XPS NITRO SYSTEM
| Applicant | Xomed, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Oct 17, 2000 |
| Received | Sep 11, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002828
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2009 | Medtronic Xomed, Inc. Medtronic Integrated Power Console System, IP X1
REF 1898001 or REF EC300
Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA.
Distributed by: Medtronic Powered Surg Terminated |
ERL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.