K010709 is an FDA 510(k) clearance for the MENTOR STERILE SALINE MAMMARY VOLUME SIZERS. This device is classified as a Mammary Sizer.
Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on April 23, 2001, 45 days after receiving the submission on March 9, 2001.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K010709 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2001 |
| Decision Date | April 23, 2001 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MRD — Mammary Sizer |
| Device Class | — |