The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Ultrasound Assisted Tissue Removal System (trs).
Device ID | K970471 |
510k Number | K970471 |
Device Name: | MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS) |
Classification | Instrument, Ultrasonic Surgical |
Applicant | MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
Contact | Clarke Scherff |
Correspondent | Clarke Scherff 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 | 1997-02-07 |
Decision Date | 1997-07-17 |
Summary: | summary |