510(k) K820362 ยท ETD Tube, Tympanostomy
REUTER BOBBIN VENTILA. TUBE-TITANIUM
| Applicant | Richard'S Medical Equip., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 2, 1982 |
| Received | Feb 9, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820362
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2010 | Gyrus ACMI Corporation MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA.
Intended to be implanted for ventilation or draina Terminated |
ETD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.