510(k) K921535 ยท KCZ Prosthesis, Breast, External, Used With Adhesive
SUOENA AFFINITY (TM) MODEL #802
| Applicant | Coloplast Corp., Marietta GA, US |
| Decision | Substantially Equivalent, May 11, 1992 |
| Received | Mar 31, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921535
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.