510(k) K061912 ยท INI Vehicle, Motorized 3-Wheeled
FUSION
| Applicant | Burke, Inc., Kansas City KS, US |
| Decision | Substantially Equivalent, Aug 1, 2006 |
| Received | Jul 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061912
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.