510(k) K081522 ยท HHT Spatula, Cervical, Cytological
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
| Applicant | Bio Nuclear Diagnostics, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Dec 5, 2008 |
| Received | May 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081522
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.