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 |