FDA 510(k) Application Details - K965115

Device Classification Name	Tube, Tympanostomy   More FDA Info for this Device
510(K) Number	K965115
Device Name	Tube, Tympanostomy
Applicant	NEURO-BIOMETRIX, INC. 3151 S. ALBION ST. DENVER, CO 80222 US Other 510(k) Applications for this Company
Contact	MICHAEL H ARENBERG 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	12/20/1996
Decision Date	03/10/1997
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