The following data is part of a premarket notification filed by Mentor Worldwide Llc with the FDA for Artoura Breast Tissue Expander.
| Device ID | K150777 |
| 510k Number | K150777 |
| Device Name: | Artoura Breast Tissue Expander |
| Classification | Expander, Skin, Inflatable |
| Applicant | MENTOR WORLDWIDE LLC 201 MENTOR DRIVE Santa Barbara, CA 93111 |
| Contact | Manchi Cheung |
| Correspondent | Manchi Cheung MENTOR WORLDWIDE LLC 201 MENTOR DRIVE Santa Barbara, CA 93111 |
| 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 | 2015-03-25 |
| Decision Date | 2015-04-24 |
| Summary: | summary |