510(k) K904086 ยท KCZ Prosthesis, Breast, External, Used With Adhesive
DISCRENE SELF-SUPPORTING BREAST FORM
| Applicant | Coloplast A/S, Fort Woth TX, US |
| Decision | Substantially Equivalent, Oct 2, 1990 |
| Received | Sep 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904086
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.