510(k) K970493 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
HYFRECATOR 2000
| Applicant | Aspen Labs, Centennial CO, US |
| Decision | Substantially Equivalent, Apr 30, 1997 |
| Received | Feb 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970493
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2003 | ConMed Electrosurgery Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220 and -230. Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.