The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Ultrasound-assisted Tissue Removal System.
| Device ID | K983065 |
| 510k Number | K983065 |
| Device Name: | MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
| Contact | Donna A Crawford |
| Correspondent | Donna A Crawford MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-02 |
| Decision Date | 1998-12-01 |
| Summary: | summary |