FDA 510(k) Application Details - K250243

Device Classification Name	Tube, Tracheal (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K250243
Device Name	Tube, Tracheal (W/Wo Connector)
Applicant	Flexicare Medical Limited Cynon Valley Business Park Mountain Ash. Rhondda Cynon Taf CF45 4ER GB Other 510(k) Applications for this Company
Contact	Rebecca Funston 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	01/27/2025
Decision Date	05/20/2025
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