510(k) K885255 ยท FFK Lithotriptor, Electro-Hydraulic
MDL-1 LASERTRIPTER(TM)
| Applicant | Candela Laser Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Jun 1, 1989 |
| Received | Dec 23, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885255
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.