FDA 510(k) Application Details - K970340

Device Classification Name	Device, Assistive Listening   More FDA Info for this Device
510(K) Number	K970340
Device Name	Device, Assistive Listening
Applicant	BELLAB GUSTAF WERNERS GATA 2 S-421 32 V. FROLUNDA GOTHENBURG SE Other 510(k) Applications for this Company
Contact	MARTIN ERIKSSON Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/29/1997
Decision Date	03/26/1997
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