510(k) K864386 ยท FSP Loupe, Diagnostic/Surgical
LUXTEC LOUPES FOR SURGICAL VISION
| Applicant | Luxtec Corp., Sturbridge MA, US |
| Decision | Substantially Equivalent, Nov 17, 1986 |
| Received | Nov 5, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864386
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.