510(k) K983868 ยท GEX Powered Laser Surgical Instrument
OPMI TWINER SURGICAL MICROSCOPE
| Applicant | Carl Zeiss, Inc., Thornwood NY, US |
| Decision | Substantially Equivalent, Jan 29, 1999 |
| Received | Nov 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983868
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.