FDA 510(k) Application Details - K151067

Device Classification Name	Tube, Tympanostomy   More FDA Info for this Device
510(K) Number	K151067
Device Name	Tube, Tympanostomy
Applicant	Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 US Other 510(k) Applications for this Company
Contact	Michelle Hughes Other 510(k) Applications for this Contact
Regulation Number	874.3880   More FDA Info for this Regulation Number
Classification Product Code	ETD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2015
Decision Date	07/22/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review