FDA 510(k) Application Details - K002221

Device Classification Name	Prosthesis, Partial Ossicular Replacement   More FDA Info for this Device
510(K) Number	K002221
Device Name	Prosthesis, Partial Ossicular Replacement
Applicant	HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-I AMSTERDAM 1017 AP NL Other 510(k) Applications for this Company
Contact	DAGMAR S MASER 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	07/24/2000
Decision Date	08/09/2000
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