FDA 510(k) Application Details - K110326

Device Classification Name	Otoscope   More FDA Info for this Device
510(K) Number	K110326
Device Name	Otoscope
Applicant	OSRAM SYLVANIA, INC. 1801 ROCKVILLE PIKE SUITE 300 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	MARIE A SCHROEDER Other 510(k) Applications for this Contact
Regulation Number	874.4770   More FDA Info for this Regulation Number
Classification Product Code	ERA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/2011
Decision Date	10/27/2011
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