FDA 510(k) Application Details - K970537

Device Classification Name	Hearing Aid, Air Conduction   More FDA Info for this Device
510(K) Number	K970537
Device Name	Hearing Aid, Air Conduction
Applicant	REXTON, INC. 2415 XENIUM LN. PLYMOUTH, MN 55441 US Other 510(k) Applications for this Company
Contact	DANIEL L ANDERSON Other 510(k) Applications for this Contact
Regulation Number	874.3300   More FDA Info for this Regulation Number
Classification Product Code	ESD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/1997
Decision Date	03/28/1997
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