FDA 510(k) Application Details - K012456

Device Classification Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece   More FDA Info for this Device
510(K) Number	K012456
Device Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant	SODEM SYSTEMS 110 CH. DU PONT DU CENTENAIRE GENEVA CH-1228 CH Other 510(k) Applications for this Company
Contact	CAROLE BURNIER 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	08/01/2001
Decision Date	09/21/2001
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