510(k) K140558 ยท PHN Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
PROCTIGARD
| Applicant | Access Pharmaceuticals, Inc., New York NY, US |
| Decision | Substantially Equivalent, Jul 16, 2014 |
| Received | Mar 5, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140558
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.