FDA 510(k) Application Details - K062458

Device Classification Name	Cannula, Sinus   More FDA Info for this Device
510(K) Number	K062458
Device Name	Cannula, Sinus
Applicant	ACCLARENT, INC. 1525-B O'BRIEN DR. MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	DEBBIE COGAN Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	KAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2006
Decision Date	09/15/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review