FDA 510(k) Application Details - K132297

Device Classification Name	Instrument, Ent Manual Surgical   More FDA Info for this Device
510(K) Number	K132297
Device Name	Instrument, Ent Manual Surgical
Applicant	MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH JACKSONVILLE, FL 32216 US Other 510(k) Applications for this Company
Contact	ROZANNE PACIEJ 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	07/24/2013
Decision Date	11/05/2013
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