FDA 510(k) Application Details - K142022

Device Classification Name	Microdebrider, Ent, High Speed, Single Use, Reprocessed   More FDA Info for this Device
510(K) Number	K142022
Device Name	Microdebrider, Ent, High Speed, Single Use, Reprocessed
Applicant	MEDLINE RENEWAL 2747 SW 6th St REDMOND, OR 97756 US Other 510(k) Applications for this Company
Contact	RICHARD D WYNKOOP Other 510(k) Applications for this Contact
Regulation Number	874.4140   More FDA Info for this Regulation Number
Classification Product Code	NLY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2014
Decision Date	12/19/2014
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