510(k) K904316 ยท KCZ Prosthesis, Breast, External, Used With Adhesive
NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT
| Applicant | Coloplast Corp., Marietta GA, US |
| Decision | Substantially Equivalent, Oct 11, 1990 |
| Received | Sep 21, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904316
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.