FDA 510(k) Application Details - K002913

Device Classification Name	Hearing Aid, Bone Conduction   More FDA Info for this Device
510(K) Number	K002913
Device Name	Hearing Aid, Bone Conduction
Applicant	ENTIFIC MEDICAL SYSTEMS, INC. 6470 RIVERVIEW TERRACE MINNEAPOLIS, MN 55432 US Other 510(k) Applications for this Company
Contact	CONSTANCE G BUNDY Other 510(k) Applications for this Contact
Regulation Number	874.3300   More FDA Info for this Regulation Number
Classification Product Code	LXB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2000
Decision Date	10/17/2000
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