510(k) K792159 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
FISCH DRILL SYSTEM
| Applicant | Jedmed Instrument Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 27, 1979 |
| Received | Oct 29, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K792159
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2020 | Bien-Air Surgery Sa Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones. Open, Classified |
ERL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.