510(k) K951324 ยท KCZ Prosthesis, Breast, External, Used With Adhesive
MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS
| Applicant | Maxol Limited L.C., Overland Park KS, US |
| Decision | Substantially Equivalent, May 26, 1995 |
| Received | Mar 23, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951324
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.