FDA 510(k) Application Details - K974224

Device Classification Name	Tube, Shunt, Endolymphatic   More FDA Info for this Device
510(K) Number	K974224
Device Name	Tube, Shunt, Endolymphatic
Applicant	EXMOOR PLASTICS LTD. LISIEUX WAY TAUNTON, SOMERSET TA1 2LB GB Other 510(k) Applications for this Company
Contact	MARGARET BLACKMORE Other 510(k) Applications for this Contact
Regulation Number	874.3820   More FDA Info for this Regulation Number
Classification Product Code	ESZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/1997
Decision Date	01/27/1998
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