510(k) K864785 ยท GBI Material, External Aesthetic Restoration, Used With Adhesive
AMOENA BREAST FORMS
| Applicant | Coloplast Corp., Marietta GA, US |
| Decision | Substantially Equivalent, Jan 8, 1987 |
| Received | Dec 8, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864785
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.