FDA 510(k) Application Details - K083780

Device Classification Name	Replacement, Ossicular Prosthesis, Total   More FDA Info for this Device
510(K) Number	K083780
Device Name	Replacement, Ossicular Prosthesis, Total
Applicant	AUDIO TECHNOLOGIES S.R.L. VIA VALLERA, 42 PIACENZA I-29100 IT Other 510(k) Applications for this Company
Contact	FRANCO BEONI Other 510(k) Applications for this Contact
Regulation Number	874.3495   More FDA Info for this Regulation Number
Classification Product Code	ETA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2008
Decision Date	03/23/2009
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