FDA 510(k) Application Details - K071178

Device Classification Name	Tube, Tympanostomy   More FDA Info for this Device
510(K) Number	K071178
Device Name	Tube, Tympanostomy
Applicant	OTOMEDICS ADVANCED MEDICAL TECHNOLOGIES, LTD. 20 HATA'AS ST. KFAR SABA 44425 IL Other 510(k) Applications for this Company
Contact	AHAVA STEIN 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	04/27/2007
Decision Date	06/22/2007
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