The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Sonicision Cordless Ultrasonic Dissector.
Device ID | K200427 |
510k Number | K200427 |
Device Name: | Sonicision Cordless Ultrasonic Dissector |
Classification | Instrument, Ultrasonic Surgical |
Applicant | Covidien, Llc 5920 Longbow Dr. Boulder, CO 80301 |
Contact | Celso Duran |
Correspondent | Celso Duran Covidien, Llc 5920 Longbow Dr. Boulder, CO 80301 |
Product Code | LFL |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-02-21 |
Decision Date | 2020-07-10 |