FDA 510(k) Application Details - K251138

Device Classification Name	More FDA Info for this Device
510(K) Number	K251138
Device Name	Promisemed Safety Huber Needles
Applicant	Promisemed Hangzhou Meditech Co., Ltd. No. 1388 Cangxing Street Cangqian Community, Yuhang District Hangzhou City 311121 CN Other 510(k) Applications for this Company
Contact	Zearou Yang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2025
Decision Date	05/13/2025
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