FDA 510(k) Application Details - K152778

Device Classification Name	Cuff, Tracheal Tube, Inflatable   More FDA Info for this Device
510(K) Number	K152778
Device Name	Cuff, Tracheal Tube, Inflatable
Applicant	TRACOE MEDICAL GMBH REICHELSHEIMER STR. 1/3 NIEDER-OLM D-55268 DE Other 510(k) Applications for this Company
Contact	STEPHAN KOHLER 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	09/25/2015
Decision Date	12/21/2016
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