FDA 510(k) Application Details - DEN050007

Device Classification Name	Kit, Test, Olfactory   More FDA Info for this Device
510(K) Number	DEN050007
Device Name	Kit, Test, Olfactory
Applicant	FMG INNOVATIONS, INC. ONE FINANCIAL CENTER BOSTON, MA 02111 US Other 510(k) Applications for this Company
Contact	LINDA D BENTLEY Other 510(k) Applications for this Contact
Regulation Number	874.1600   More FDA Info for this Regulation Number
Classification Product Code	NRK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2005
Decision Date	03/27/2006
Decision	DENG -
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review