FDA 510(k) Application Details - K250658

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K250658
Device Name	Needle, Hypodermic, Single Lumen
Applicant	SHINA MED CORPORATION 455-30, Bogaewonsam-ro, Bogae-myeon, Anseong-si, Gyeonggi-do, Republic of Korea Anseong 17509 KR Other 510(k) Applications for this Company
Contact	Taejoo Ha 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	03/05/2025
Decision Date	04/03/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review