FDA 510(k) Application Details - K213028

Device Classification Name	Tube, Tracheal (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K213028
Device Name	Tube, Tracheal (W/Wo Connector)
Applicant	Bryan Medical , Inc. 5725 Dragon Way, Suite 300 Cincinnati, OH 45227 US Other 510(k) Applications for this Company
Contact	Andrew J Georgilis Other 510(k) Applications for this Contact
Regulation Number	868.5730   More FDA Info for this Regulation Number
Classification Product Code	BTR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/21/2021
Decision Date	10/21/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review