510(k) K915382 ยท KCZ Prosthesis, Breast, External, Used With Adhesive
AMOENA AFFINITY MODEL #802
| Applicant | Coloplast Corp., Marietta GA, US |
| Decision | Substantially Equivalent, Jan 14, 1992 |
| Received | Nov 29, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915382
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.