510(k) K111831 ยท ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
MX-7000 MICROXEL
| Applicant | Bio-Med USA, Inc., Paterson NJ, US |
| Decision | Substantially Equivalent, Dec 19, 2011 |
| Received | Jun 28, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111831
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.