510(k) K912046 ยท HGI Electrocautery, Gynecologic (And Accessories)
SINGLE USE LEE ELECTRODE
| Applicant | Aspen Labs, Englewood CO, US |
| Decision | Substantially Equivalent, Mar 5, 1992 |
| Received | May 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912046
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.