FDA 510(k) Application Details - K173914

Device Classification Name	Cuff, Tracheal Tube, Inflatable   More FDA Info for this Device
510(K) Number	K173914
Device Name	Cuff, Tracheal Tube, Inflatable
Applicant	VORTRAN Medical Technology 1, Inc. 21 Goldenland Court #100 Sacramento, CA 95834 US Other 510(k) Applications for this Company
Contact	James Lee 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	12/22/2017
Decision Date	05/25/2018
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