FDA 510(k) Application Details - K001142

Device Classification Name	Prosthesis, Partial Ossicular Replacement   More FDA Info for this Device
510(K) Number	K001142
Device Name	Prosthesis, Partial Ossicular Replacement
Applicant	AUDIO TECHNOLOGIES S.R.L. VIA DELL'ARTIGINATO, 8 GOSSOLENGO PIACENZA 29020 IT Other 510(k) Applications for this Company
Contact	FRANCO BEONI Other 510(k) Applications for this Contact
Regulation Number	874.3450   More FDA Info for this Regulation Number
Classification Product Code	ETB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2000
Decision Date	06/23/2000
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