510(k) K812422 ยท IPY Orthosis, Lumbo-Sacral
CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS
| Applicant | Surgical Appliance Industries, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 14, 1981 |
| Received | Aug 24, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812422
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.