FDA 510(k) Application Details - K213407

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K213407
Device Name	Needle, Hypodermic, Single Lumen
Applicant	UltiMed Incorporated 350 Highway 7, Suite 100 Excelsior, MN 55331 US Other 510(k) Applications for this Company
Contact	Paul Lewis 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	10/19/2021
Decision Date	12/16/2021
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	Y
Expedited Review