FDA 510(k) Application Details - K992872

Device Classification Name	Hearing Aid, Bone Conduction   More FDA Info for this Device
510(K) Number	K992872
Device Name	Hearing Aid, Bone Conduction
Applicant	ENTIFIC MEDICAL SYSTEMS, INC. 8944 TAMAROA TERRACE SKOKIE, IL 60076 US Other 510(k) Applications for this Company
Contact	BESTY A BROWN 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	08/26/1999
Decision Date	11/24/1999
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