FDA 510(k) Application Details - K201398

Device Classification Name	Instrument, Ent Manual Surgical   More FDA Info for this Device
510(K) Number	K201398
Device Name	Instrument, Ent Manual Surgical
Applicant	Stryker ENT 3600 Holly Lane North, Suite 40 Plymouth, MN 55447 US Other 510(k) Applications for this Company
Contact	Bruce Backlund Other 510(k) Applications for this Contact
Regulation Number	874.4420   More FDA Info for this Regulation Number
Classification Product Code	LRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2020
Decision Date	10/15/2020
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