510(k) K052891 ยท HNO Keratome, Ac-Powered
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
| Applicant | Hawken Industries, Hasbrouck Heights NJ, US |
| Decision | Substantially Equivalent, Mar 23, 2006 |
| Received | Oct 13, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052891
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.