K130813 is an FDA 510(k) clearance for the MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS. This device is classified as a Tissue Expander And Accessories.
Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on April 11, 2013, 17 days after receiving the submission on March 25, 2013.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K130813 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2013 |
| Decision Date | April 11, 2013 |
| Days to Decision | 17 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LCJ — Tissue Expander And Accessories |
| Device Class | — |