510(k) K853822 ยท GBI Material, External Aesthetic Restoration, Used With Adhesive
AMOENA BREAST FORMS
| Applicant | Coloplast Corp., Marietta GA, US |
| Decision | Substantially Equivalent, Sep 30, 1985 |
| Received | Sep 13, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853822
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.