510(k) K111443 ยท OLO Orthopedic Stereotaxic Instrument
X12 STERILE REFLECTIVE MARKER SPHERE
| Applicant | Pinsco Inc. Dba B & L Engineering, Santa Ana CA, US |
| Decision | Substantially Equivalent, Sep 29, 2011 |
| Received | May 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111443
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.