The following data is part of a premarket notification filed by Mentor Worldwide Llc with the FDA for Artoura Breast Tissue Expanders With Smooth Surface.
| Device ID | K161176 |
| 510k Number | K161176 |
| Device Name: | ARTOURA Breast Tissue Expanders With Smooth Surface |
| Classification | Expander, Skin, Inflatable |
| Applicant | MENTOR WORLDWIDE LLC 33 TECHNOLOGY DRIVE Irvine, CA 92618 |
| Contact | Laura C. Vellucci |
| Correspondent | Laura C. Vellucci MENTOR WORLDWIDE LLC 33 TECHNOLOGY DRIVE Irvine, CA 92618 |
| 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 | 2016-04-26 |
| Decision Date | 2016-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00081317024415 | K161176 | 000 |
| 10081317028274 | K161176 | 000 |
| 10081317028267 | K161176 | 000 |
| 10081317028250 | K161176 | 000 |
| 10081317028243 | K161176 | 000 |
| 10081317028236 | K161176 | 000 |
| 10081317028229 | K161176 | 000 |
| 10081317028212 | K161176 | 000 |
| 10081317028205 | K161176 | 000 |
| 10081317028199 | K161176 | 000 |
| 10081317028182 | K161176 | 000 |
| 10081317028175 | K161176 | 000 |
| 10081317028168 | K161176 | 000 |
| 10081317028281 | K161176 | 000 |
| 00081317024286 | K161176 | 000 |
| 00081317024408 | K161176 | 000 |
| 00081317024392 | K161176 | 000 |
| 00081317024385 | K161176 | 000 |
| 00081317024378 | K161176 | 000 |
| 00081317024361 | K161176 | 000 |
| 00081317024354 | K161176 | 000 |
| 00081317024347 | K161176 | 000 |
| 00081317024330 | K161176 | 000 |
| 00081317024323 | K161176 | 000 |
| 00081317024316 | K161176 | 000 |
| 00081317024309 | K161176 | 000 |
| 00081317024293 | K161176 | 000 |
| 10081317028151 | K161176 | 000 |