510(k) K182831 ยท GEX Powered Laser Surgical Instrument
SabreLine and SabreGuard Laser Fibers
| Applicant | Coloplast Corp., Plymouth MN, US |
| Decision | Substantially Equivalent, Dec 10, 2018 |
| Received | Oct 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182831
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.