FDA 510(k) Application Details - K082188

Device Classification Name	Tube, Tympanostomy   More FDA Info for this Device
510(K) Number	K082188
Device Name	Tube, Tympanostomy
Applicant	ACCLARENT, INC. 1525-B O'BRIEN DR. MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	KERI YEN 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	08/04/2008
Decision Date	09/19/2008
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