510(k) K984537 ยท HMY Keratome, Battery-Powered
KERATOME SYSTEM, MODEL K3000
| Applicant | Insight Technologies Instruments, LLC, Milford CT, US |
| Decision | Substantially Equivalent, May 14, 1999 |
| Received | Dec 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984537
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.