510(k) K974243 ยท HMY Keratome, Battery-Powered
KERATOME SYSTEM
| Applicant | Insight Technologies Instruments, LLC, Milford CT, US |
| Decision | Substantially Equivalent, Jan 20, 1998 |
| Received | Nov 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974243
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.