The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Ultrasound-assisted Tissue Removal System (current), Mentor Contour Genesis System (proposed).
| Device ID | K004005 |
| 510k Number | K004005 |
| Device Name: | MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) |
| Classification | System, Suction, Lipoplasty |
| Applicant | MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
| Contact | Donna A Crawford |
| Correspondent | Donna A Crawford MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-26 |
| Decision Date | 2001-10-12 |