The following data is part of a premarket notification filed by Miconvey Technologies Co., Ltd. with the FDA for Ultrasonic Surgical System.
Device ID | K210567 |
510k Number | K210567 |
Device Name: | Ultrasonic Surgical System |
Classification | Instrument, Ultrasonic Surgical |
Applicant | Miconvey Technologies Co., Ltd. No.16 Fangzheng Avenue, Beibei District Chongqing, CN 400714 |
Contact | Kang Li |
Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
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 | 2021-02-26 |
Decision Date | 2022-09-30 |