FDA 510(k) Application Details - K992138

Device Classification Name	Replacement, Ossicular Prosthesis, Total   More FDA Info for this Device
510(K) Number	K992138
Device Name	Replacement, Ossicular Prosthesis, Total
Applicant	MICROMEDICS, INC. 1285 CORPORATE CENTER DR., #150 EAGAN, MN 55121 US Other 510(k) Applications for this Company
Contact	CHARLES GROTE 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	06/24/1999
Decision Date	08/09/1999
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