510(k) K862150 ยท EWG Laser, Ent Microsurgical Carbon-Dioxide
MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)
| Applicant | Directed Energy, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent for Some Indications, Sep 4, 1986 |
| Received | Jun 4, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862150
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.