FDA 510(k) Application Details - K061058

Device Classification Name	Tube, Tympanostomy   More FDA Info for this Device
510(K) Number	K061058
Device Name	Tube, Tympanostomy
Applicant	ADEPT MEDICAL LTD P.O. BOX 10075 DOMINION ROAD AUCKLAND NZ Other 510(k) Applications for this Company
Contact	JASON MARSH 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	04/17/2006
Decision Date	07/12/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review