The following data is part of a premarket notification filed by Medisonic Technology Co with the FDA for Ultrasonic Surgical System.
| Device ID | K190281 |
| 510k Number | K190281 |
| Device Name: | Ultrasonic Surgical System |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | MediSonic Technology Co 11411 Southern Highlands Parkway, Suite 300 Las Vegas, NV 89141 |
| Contact | Reginald Bart-williams |
| Correspondent | John Gillespy FDA 510k Consultants, LLC 1100 Del Lago Cir #104 Palm Beach Gardens, FL 33410 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-11 |
| Decision Date | 2019-10-31 |