FDA 510(k) Application Details - K963899

Device Classification Name	Replacement, Ossicular Prosthesis, Total   More FDA Info for this Device
510(K) Number	K963899
Device Name	Replacement, Ossicular Prosthesis, Total
Applicant	EXMOOR PLASTICS LTD. LISIEUX WAY TAUNTON, SOMERSET TA1 2LB GB Other 510(k) Applications for this Company
Contact	BRIAN EAST 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	09/27/1996
Decision Date	08/22/1997
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