FDA 510(k) Application Details - K984162

Device Classification Name	Hearing Aid, Bone Conduction, Implanted   More FDA Info for this Device
510(K) Number	K984162
Device Name	Hearing Aid, Bone Conduction, Implanted
Applicant	NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 WESTMONT, IL 60559 US Other 510(k) Applications for this Company
Contact	BETSY A BROWN Other 510(k) Applications for this Contact
Regulation Number	874.3300   More FDA Info for this Regulation Number
Classification Product Code	MAH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/1998
Decision Date	06/28/1999
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