The following data is part of a premarket notification filed by Mentor Worldwide Llc with the FDA for Cpx 4 Breast Tissue Expander With Smooth Surface.
| Device ID | K182335 |
| 510k Number | K182335 |
| Device Name: | CPX 4 Breast Tissue Expander With Smooth Surface |
| Classification | Expander, Skin, Inflatable |
| Applicant | Mentor Worldwide LLC 33 Technology Drive Irvine, CA 92618 |
| Contact | Martin Sprunck |
| Correspondent | Martin Sprunck 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 | 2018-08-28 |
| Decision Date | 2018-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00081317026761 | K182335 | 000 |
| 10081317028465 | K182335 | 000 |
| 10081317028458 | K182335 | 000 |
| 10081317028441 | K182335 | 000 |
| 10081317028434 | K182335 | 000 |
| 10081317028427 | K182335 | 000 |
| 10081317028410 | K182335 | 000 |
| 10081317028403 | K182335 | 000 |
| 10081317028397 | K182335 | 000 |
| 10081317028380 | K182335 | 000 |
| 10081317028373 | K182335 | 000 |
| 10081317028366 | K182335 | 000 |
| 10081317028359 | K182335 | 000 |
| 10081317028342 | K182335 | 000 |
| 10081317028335 | K182335 | 000 |
| 10081317028328 | K182335 | 000 |
| 10081317028311 | K182335 | 000 |
| 10081317028304 | K182335 | 000 |
| 10081317028472 | K182335 | 000 |
| 00081317026587 | K182335 | 000 |
| 00081317026754 | K182335 | 000 |
| 00081317026747 | K182335 | 000 |
| 00081317026730 | K182335 | 000 |
| 00081317026723 | K182335 | 000 |
| 00081317026716 | K182335 | 000 |
| 00081317026709 | K182335 | 000 |
| 00081317026693 | K182335 | 000 |
| 00081317026686 | K182335 | 000 |
| 00081317026679 | K182335 | 000 |
| 00081317026662 | K182335 | 000 |
| 00081317026655 | K182335 | 000 |
| 00081317026648 | K182335 | 000 |
| 00081317026631 | K182335 | 000 |
| 00081317026624 | K182335 | 000 |
| 00081317026617 | K182335 | 000 |
| 00081317026600 | K182335 | 000 |
| 00081317026594 | K182335 | 000 |
| 10081317028298 | K182335 | 000 |