FDA 510(k) Application Details - K123842

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K123842
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. LANGSHAN 2ND STREET NANSHAN DISTRICT SHENZHENG, GUANGDONG 518057 CN Other 510(k) Applications for this Company
Contact	LILY SHI Other 510(k) Applications for this Contact
Regulation Number	870.1310   More FDA Info for this Regulation Number
Classification Product Code	DRE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2012
Decision Date	06/24/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review