FDA 510(k) Application Details - K240915

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K240915
Device Name	Needle, Hypodermic, Single Lumen
Applicant	ZIEN Medical Technologies, Inc. 2490 South 300 West Salt Lake City, UT 84115 US Other 510(k) Applications for this Company
Contact	Tim Nieman 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	04/03/2024
Decision Date	07/02/2024
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