FDA 510(k) Application Details - K974219

Device Classification Name	Face Plate Hearing Aid   More FDA Info for this Device
510(K) Number	K974219
Device Name	Face Plate Hearing Aid
Applicant	FINETONE HEARING INSTRUMENTS 301 U.S. RT. 1 SCARBOROUGH, ME 04074 US Other 510(k) Applications for this Company
Contact	PAUL MENEZES Other 510(k) Applications for this Contact
Regulation Number	874.3300   More FDA Info for this Regulation Number
Classification Product Code	LRB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/1997
Decision Date	02/20/1998
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