510(k) K983065
K983065 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM". The FDA issued a decision of Substantially Equivalent on December 1, 1998. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Mentor Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 1998
- Date Received
- September 2, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ultrasonic Surgical
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type