The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Natrelle 133 Plus Tissue Expander.
| Device ID | K143354 |
| 510k Number | K143354 |
| Device Name: | Natrelle 133 Plus Tissue Expander |
| Classification | Expander, Skin, Inflatable |
| Applicant | ALLERGAN, INC. 2525 DUPONT DRIVE Irvine, CA 92623 -9534 |
| Contact | Bruce Krattenmaker |
| Correspondent | Bruce Krattenmaker ALLERGAN, INC. 2525 DUPONT DRIVE Irvine, CA 92623 -9534 |
| 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 | 2014-11-24 |
| Decision Date | 2015-08-20 |
| Summary: | summary |