510(k) K861845 ยท HHR Laser, Surgical, Gynecologic
MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE
| Applicant | Directed Energy, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Aug 11, 1986 |
| Received | May 13, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861845
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.