510(k) K830228 ยท ETD Tube, Tympanostomy
OTOLOGICAL VENTILATION TUBES-VARIOUS
| Applicant | Micromedics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 7, 1983 |
| Received | Jan 24, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830228
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2014 | Summit Medical, Inc. Armstrong Grommet with wire Otological Ventilation Tube
Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only.
Intended to provide ventilation to the middle ear space through the tympanic mem Terminated |
ETD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.