510(k) K965123 ยท INI Vehicle, Motorized 3-Wheeled
PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)
| Applicant | Burke, Inc., Kansas City KS, US |
| Decision | Substantially Equivalent, Jul 17, 1997 |
| Received | Nov 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965123
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.