FDA 510(k) Application Details - K971124

Device Classification Name	Tube, Tympanostomy   More FDA Info for this Device
510(K) Number	K971124
Device Name	Tube, Tympanostomy
Applicant	XOMED, INC. 6743 SOUTHPOINT DR. NORTH JACKSONVILLE, FL 32216-0980 US Other 510(k) Applications for this Company
Contact	DAVID TIMLIN Other 510(k) Applications for this Contact
Regulation Number	874.3880   More FDA Info for this Regulation Number
Classification Product Code	ETD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/1997
Decision Date	05/16/1997
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