K182054 is an FDA 510(k) clearance for the Natrelle 133S Tissue Expander. This device is classified as a Tissue Expander And Accessories.
Submitted by Allergan (Irvine, US). The FDA issued a Cleared decision on August 29, 2018, 29 days after receiving the submission on July 31, 2018.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K182054 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2018 |
| Decision Date | August 29, 2018 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LCJ - Tissue Expander And Accessories |
| Device Class | - |