FDA 510(k) Application Details - K971517

Device Classification Name	Protector, Hearing (Insert)   More FDA Info for this Device
510(K) Number	K971517
Device Name	Protector, Hearing (Insert)
Applicant	BENTEC MEDICAL, INC. 4234 NORTH FREEWAY BLVD. SACRAMENTO, CA 95834 US Other 510(k) Applications for this Company
Contact	LOUIS R MATSON Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	EWD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/1997
Decision Date	06/02/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review