The following data is part of a premarket notification filed by Smtp Technology Co., Ltd with the FDA for Ultrasonic Surgical Aspirator System.
| Device ID | K202299 |
| 510k Number | K202299 |
| Device Name: | Ultrasonic Surgical Aspirator System |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | SMTP Technology Co., Ltd 1F&4F, Building A, Emerging Industry Incubation Center Zhangjiagang, CN 215634 |
| Contact | Songtao Zhan |
| Correspondent | Randy Jiang Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| 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 | 2020-08-13 |
| Decision Date | 2021-05-21 |