FDA 510(k) Application Details - K073399

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K073399
Device Name	Kit, Needle, Biopsy
Applicant	ENVISIONEERING, LLC. 1982 INNERBELT BUSINESS CTR DR ST. LOUIS, MO 63114 US Other 510(k) Applications for this Company
Contact	DAVID KENNEDY Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	FCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2007
Decision Date	12/21/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review