FDA 510(k) Application Details - K223643

Device Classification Name	More FDA Info for this Device
510(K) Number	K223643
Device Name	Verifine« Ease Lancing Device, Verifine« Lancing Device
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	QRL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2022
Decision Date	02/21/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review