FDA 510(k) Application Details - K230070

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K230070
Device Name	Needle, Hypodermic, Single Lumen
Applicant	PromaMedical Inc. 4585 Ponce De Leon Blvd. Suite 719 Miami, FL 33146 US Other 510(k) Applications for this Company
Contact	Christian Wehrenpfenning 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	01/10/2023
Decision Date	10/05/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review