FDA 510(k) Application Details - K130581

Device Classification Name	Media,Coupling,Ultrasound   More FDA Info for this Device
510(K) Number	K130581
Device Name	Media,Coupling,Ultrasound
Applicant	TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA 2237 CHESTNUT STREET SAN FRANCISCO, CA 94123 US Other 510(k) Applications for this Company
Contact	MICHAEL SCOTT, REGULATORY AGENT 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	03/05/2013
Decision Date	06/18/2014
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