510(k) K091320 ยท GEX Powered Laser Surgical Instrument
SPECTRA SP II, SPECTRA DENTA II
| Applicant | Lutronic Corporation, North Reading MA, US |
| Decision | Substantially Equivalent, Aug 19, 2009 |
| Received | May 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091320
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.