510(k) K011338 ยท NEA Cement, Ear, Nose And Throat
OTO-CEM
| Applicant | Ototech, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Sep 13, 2001 |
| Received | May 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011338
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.