510(k) K190281
K190281 is an FDA 510(k) premarket notification submitted by Medisonic Technology CO for the device "Ultrasonic Surgical System". The FDA issued a decision of Substantially Equivalent on Oct 31, 2019. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 31, 2019
- Date Received
- Feb 11, 2019
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ultrasonic Surgical
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)