FDA 510(k) Application Details - K002897

Device Classification Name	Prosthesis, Partial Ossicular Replacement   More FDA Info for this Device
510(K) Number	K002897
Device Name	Prosthesis, Partial Ossicular Replacement
Applicant	XOMED, INC. 6743 SOUTHPOINT DR. NORTH JACKSONVILLE, FL 32216-0980 US Other 510(k) Applications for this Company
Contact	DAVID TIMLIN 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	09/18/2000
Decision Date	10/11/2000
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