FDA 510(k) Application Details - K161514

Device Classification Name	Bur, Ear, Nose And Throat   More FDA Info for this Device
510(K) Number	K161514
Device Name	Bur, Ear, Nose And Throat
Applicant	STRYKER CORPORATION 4100 E. MILHAM AVE KALAMAZOO, MI 49009 US Other 510(k) Applications for this Company
Contact	Joanna McCarthy Other 510(k) Applications for this Contact
Regulation Number	874.4140   More FDA Info for this Regulation Number
Classification Product Code	EQJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2016
Decision Date	01/17/2017
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