FDA 510(k) Application Details - K202874

Device Classification Name	Cuff, Tracheal Tube, Inflatable   More FDA Info for this Device
510(K) Number	K202874
Device Name	Cuff, Tracheal Tube, Inflatable
Applicant	Covidien llc 6F, Building 3, 2388 Chenhang Road Shanghai 201114 CN Other 510(k) Applications for this Company
Contact	Jenny Liu Other 510(k) Applications for this Contact
Regulation Number	868.5750   More FDA Info for this Regulation Number
Classification Product Code	BSK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2020
Decision Date	01/09/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review