FDA 510(k) Application Details - K092338

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K092338
Device Name	Instrument, Biopsy
Applicant	MEDAX UNIPERSONALE SRL 3016 N.W. 82ND AVE. MIAMI, FL 33122 US Other 510(k) Applications for this Company
Contact	FLAVIO TOMASSINI Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	KNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2009
Decision Date	05/27/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review