FDA 510(k) Application Details - K970665

Device Classification Name	Hearing Aid, Group And Auditory Trainer   More FDA Info for this Device
510(K) Number	K970665
Device Name	Hearing Aid, Group And Auditory Trainer
Applicant	WILLIAMS SOUND, LLC 10300 Valley View Rd EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	PAUL INGEBRIGTSEN Other 510(k) Applications for this Contact
Regulation Number	874.3320   More FDA Info for this Regulation Number
Classification Product Code	EPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/1997
Decision Date	05/02/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review