FDA 510(k) Application Details - K182146

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K182146
Device Name	Needle, Hypodermic, Single Lumen
Applicant	Sol-Millennium Medical, Inc. 1735 North Brown Road, Suite 120 Lawrenceville, GA 30043 US Other 510(k) Applications for this Company
Contact	James Barley 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	08/08/2018
Decision Date	12/03/2018
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