FDA 510(k) Application Details - K121311

Device Classification Name	Media,Coupling,Ultrasound   More FDA Info for this Device
510(K) Number	K121311
Device Name	Media,Coupling,Ultrasound
Applicant	CLOVERLINE INTERNATIONAL PHARMA SERVICES GMBH 2670 LEAVENWORTH STREET SAN FRANCISCO, CA 94133 US Other 510(k) Applications for this Company
Contact	CHRISTINA BERNSTEIN 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	05/01/2012
Decision Date	08/30/2012
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