The following data is part of a premarket notification filed by Allergan with the FDA for Natrelle 133s Tissue Expander.
Device ID | K182054 |
510k Number | K182054 |
Device Name: | Natrelle 133S 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-31 |
Decision Date | 2018-08-29 |
Summary: | summary |