510(k) K831566 ยท MRD Mammary Sizer
CUI MAMMARY PROTHESIS SIZER
| Applicant | Cox-Uphuff Intl., Walker MI, US |
| Decision | Substantially Equivalent, Aug 12, 1983 |
| Received | May 16, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831566
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2019 | Allergan PLC NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L Terminated |
MRD | None listed |
| Jul 7, 2015 | Allergan Inc Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410.
The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton. Terminated |
MRD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.