FDA 510(k) Application Details - K083358

Device Classification Name	Media,Coupling,Ultrasound   More FDA Info for this Device
510(K) Number	K083358
Device Name	Media,Coupling,Ultrasound
Applicant	FARCO PHARMA GMBH 555 ELEVENTH STREET NW WASHINGTON, DC 20004-1304 US Other 510(k) Applications for this Company
Contact	SETH A MAILHOT Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	MUI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2008
Decision Date	01/09/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review