510(k) K013151 ยท HRG Engine, Trephine, Accessories, Ac-Powered
ASMOTOM AUTOMATED TREPHINE SYSTEM
| Applicant | Bkg Opthalmics USA, Inc., Appollo Beach FL, US |
| Decision | Substantially Equivalent, Dec 14, 2001 |
| Received | Sep 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013151
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.