K831566 is an FDA 510(k) clearance for the CUI MAMMARY PROTHESIS SIZER. This device is classified as a Mammary Sizer.
Submitted by Cox-Uphuff Intl. (Walker, US). The FDA issued a Cleared decision on August 12, 1983, 88 days after receiving the submission on May 16, 1983.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K831566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 1983 |
| Decision Date | August 12, 1983 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | MRD — Mammary Sizer |
| Device Class | — |