K143354 is an FDA 510(k) clearance for the Natrelle 133 Plus Tissue Expander. This device is classified as a Tissue Expander And Accessories.
Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on August 20, 2015, 269 days after receiving the submission on November 24, 2014.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K143354 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2014 |
| Decision Date | August 20, 2015 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LCJ - Tissue Expander And Accessories |
| Device Class | - |