510(k) K982594 ยท EOB Nasopharyngoscope (Flexible Or Rigid)
ENDO-SCRUB/ENDO-SCRUB 2
| Applicant | Xomed, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Aug 27, 1998 |
| Received | Jul 24, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982594
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Medtronic Xomed, Inc. The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths Terminated |
FED | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.