FDA 510(k) Application Details - K152877

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K152877
Device Name	Needle, Hypodermic, Single Lumen
Applicant	SHINA MED CORPORATION 455-30, BOGAEWONSAM-RO, BOGAE-MYUN ANSEONG-SI 456-871 KR Other 510(k) Applications for this Company
Contact	SUNG-SOON PARK Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	FMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2015
Decision Date	06/07/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review