FDA 510(k) Application Details - K030492

Device Classification Name	Replacement, Ossicular Prosthesis, Total   More FDA Info for this Device
510(K) Number	K030492
Device Name	Replacement, Ossicular Prosthesis, Total
Applicant	INVOTEC INTERNATIONAL, INC. 6833 PHILLIPS INDUSTRIAL BLVD. JACKSONVILLE, FL 32256-3029 US Other 510(k) Applications for this Company
Contact	JEFFREY L AULL 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	02/19/2003
Decision Date	03/03/2003
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