FDA 510(k) Application Details - K972585

Device Classification Name	Replacement, Ossicular Prosthesis, Total   More FDA Info for this Device
510(K) Number	K972585
Device Name	Replacement, Ossicular Prosthesis, Total
Applicant	HEINZ KURZ GMBH MEDIZINTECHNIK TUBINGER STRASSE 3 DUSSLINGEN D-72144 DE Other 510(k) Applications for this Company
Contact	DAGMAR S MASER 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	07/10/1997
Decision Date	08/04/1997
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