510(k) K122603 ยท HEB Tampon, Menstrual, Unscented
ONTEX AND OTHER PROPRIETARY NAMES
| Applicant | Ontex Bvba, Old Lyme CT, US |
| Decision | Substantially Equivalent, Dec 19, 2012 |
| Received | Aug 27, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122603
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.