FDA 510(k) Application Details - K193077

Device Classification Name	Tube Tracheostomy And Tube Cuff   More FDA Info for this Device
510(K) Number	K193077
Device Name	Tube Tracheostomy And Tube Cuff
Applicant	Covidien 6135 Gunbarrel Ave Boulder, CO 80301 US Other 510(k) Applications for this Company
Contact	Stacy Barton Other 510(k) Applications for this Contact
Regulation Number	868.5800   More FDA Info for this Regulation Number
Classification Product Code	JOH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2019
Decision Date	06/01/2020
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