510(k) K901016 ยท GEX Powered Laser Surgical Instrument
LASER-SHIELD II(TM)
| Applicant | Xomed, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Aug 29, 1990 |
| Received | Mar 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901016
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.