The following data is part of a premarket notification filed by Covidien, Formerly Valleylab, A Division Of Tyco H with the FDA for Sonicision Cordless Ultrasonic Dissector.
Device ID | K141371 |
510k Number | K141371 |
Device Name: | SONICISION CORDLESS ULTRASONIC DISSECTOR |
Classification | Instrument, Ultrasonic Surgical |
Applicant | COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H 5920 Longbow Dr Boulder, CO 80301 |
Contact | David Horton |
Correspondent | David Horton COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H 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 | 2014-05-27 |
Decision Date | 2014-08-07 |
Summary: | summary |