The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Contour Profile Tissue Expander.
| Device ID | K011500 |
| 510k Number | K011500 |
| Device Name: | MENTOR CONTOUR PROFILE TISSUE EXPANDER |
| Classification | Expander, Skin, Inflatable |
| Applicant | MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
| Contact | Donna Crawford |
| Correspondent | Donna Crawford MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
| 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 | 2001-05-16 |
| Decision Date | 2001-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00081317004042 | K011500 | 000 |
| 00081317002352 | K011500 | 000 |
| 00081317002345 | K011500 | 000 |
| 00081317002338 | K011500 | 000 |
| 00081317002321 | K011500 | 000 |
| 00081317002314 | K011500 | 000 |
| 00081317002307 | K011500 | 000 |
| 00081317002291 | K011500 | 000 |
| 00081317002284 | K011500 | 000 |
| 00081317002277 | K011500 | 000 |
| 00081317002260 | K011500 | 000 |
| 00081317002253 | K011500 | 000 |
| 00081317002246 | K011500 | 000 |
| 00081317002239 | K011500 | 000 |
| 00081317002222 | K011500 | 000 |
| 00081317002215 | K011500 | 000 |
| 00081317002208 | K011500 | 000 |
| 00081317002192 | K011500 | 000 |
| 00081317002369 | K011500 | 000 |
| 00081317003618 | K011500 | 000 |
| 00081317003625 | K011500 | 000 |
| 00081317003793 | K011500 | 000 |
| 00081317003786 | K011500 | 000 |
| 00081317003779 | K011500 | 000 |
| 00081317003762 | K011500 | 000 |
| 00081317003755 | K011500 | 000 |
| 00081317003748 | K011500 | 000 |
| 00081317003731 | K011500 | 000 |
| 00081317003724 | K011500 | 000 |
| 00081317003717 | K011500 | 000 |
| 00081317003700 | K011500 | 000 |
| 00081317003694 | K011500 | 000 |
| 00081317003687 | K011500 | 000 |
| 00081317003670 | K011500 | 000 |
| 00081317003663 | K011500 | 000 |
| 00081317003656 | K011500 | 000 |
| 00081317003649 | K011500 | 000 |
| 00081317003632 | K011500 | 000 |
| 00081317002185 | K011500 | 000 |