FDA 510(k) Application Details - K203362

Device Classification Name	Tube Tracheostomy And Tube Cuff   More FDA Info for this Device
510(K) Number	K203362
Device Name	Tube Tracheostomy And Tube Cuff
Applicant	TRACOE medical GmbH Reichelsheimer Str. 1/3 Nieder-Olm 55268 DE Other 510(k) Applications for this Company
Contact	Katharina Schrick 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	11/16/2020
Decision Date	08/05/2021
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