FDA 510(k) Application Details - K081814

Device Classification Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece   More FDA Info for this Device
510(K) Number	K081814
Device Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant	STERILMED, INC. 11400 73RD AVE. N, STE. 100 MAPLE GROVE, MN 55369 US Other 510(k) Applications for this Company
Contact	JOSHUA CLARIN 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	06/26/2008
Decision Date	12/17/2008
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