FDA 510(k) Application Details - K001404

Device Classification Name	Replacement, Ossicular Prosthesis, Total   More FDA Info for this Device
510(K) Number	K001404
Device Name	Replacement, Ossicular Prosthesis, Total
Applicant	MEDNET LOCATOR, INC. 7000 SHADOW OAKS MEMPHIS, TN 38125 US Other 510(k) Applications for this Company
Contact	JUDY CHANDLER 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	05/03/2000
Decision Date	08/08/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review