FDA 510(k) Application Details - K041523

Device Classification Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece   More FDA Info for this Device
510(K) Number	K041523
Device Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant	MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH JACKSONVILLE, FL 32216 US Other 510(k) Applications for this Company
Contact	MARTIN D SARGENT Other 510(k) Applications for this Contact
Regulation Number	874.4250   More FDA Info for this Regulation Number
Classification Product Code	ERL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/2004
Decision Date	07/23/2004
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