FDA 510(k) Application Details - K002378

Device Classification Name	Replacement, Ossicular Prosthesis, Total   More FDA Info for this Device
510(K) Number	K002378
Device Name	Replacement, Ossicular Prosthesis, Total
Applicant	GYRUS ENT L.L.C. 2925 APPLING RD. BARTLETT, TN 38133 US Other 510(k) Applications for this Company
Contact	ALICIA FARAGE 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	08/04/2000
Decision Date	08/29/2000
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