FDA 510(k) Application Details - K250284

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K250284
Device Name	Needle, Hypodermic, Single Lumen
Applicant	TSK Laboratory, Japan 1510-1, Soja-Machi, Tochigi-Shi Tochigi-Ken 328-0002 JP Other 510(k) Applications for this Company
Contact	Yumi Ueda 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	01/31/2025
Decision Date	07/24/2025
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