K180826 is an FDA 510(k) clearance for the Natrelle 133 Plus MICROCELL Tissue Expander. This device is classified as a Tissue Expander And Accessories.
Submitted by Allergan (Irvine, US). The FDA issued a Cleared decision on December 21, 2018, 266 days after receiving the submission on March 30, 2018.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K180826 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2018 |
| Decision Date | December 21, 2018 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LCJ - Tissue Expander And Accessories |
| Device Class | - |