The following data is part of a premarket notification filed by Allergan with the FDA for Natrelle 133 Plus Microcell Tissue Expander.
| Device ID | K180826 |
| 510k Number | K180826 |
| Device Name: | Natrelle 133 Plus MICROCELL Tissue Expander |
| Classification | Expander, Skin, Inflatable |
| Applicant | Allergan 2525 Dupont Drive Irvine, CA 92612 |
| Contact | Melissa Pathmajeyan |
| Correspondent | Melissa Pathmajeyan Allergan 2525 Dupont Drive Irvine, CA 92612 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-30 |
| Decision Date | 2018-12-21 |
| Summary: | summary |