The following data is part of a premarket notification filed by Cox-uphuff Intl. with the FDA for Cui Mammary Prothesis Sizer.
| Device ID | K831566 |
| 510k Number | K831566 |
| Device Name: | CUI MAMMARY PROTHESIS SIZER |
| Classification | Sizer, Mammary, Breast Implant Volume |
| Applicant | COX-UPHUFF INTL. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | MRD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-16 |
| Decision Date | 1983-08-12 |