FDA 510(k) Application Details - DEN090007

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN090007
Device Name	BIO-SEAL LUNG BIOPSY TRACT SYSTEM
Applicant	ANGIOTECH 1618 STATION STREET VANCOUVER, BC V6A 1B6 CA Other 510(k) Applications for this Company
Contact	TRUDY ESTRIDGE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OMT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2009
Decision Date	12/19/2012
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review