FDA 510(k) Application Details - K251694

Device Classification Name	Lancet, Blood   More FDA Info for this Device
510(K) Number	K251694
Device Name	Lancet, Blood
Applicant	Tianjin Huahong Technology Co., Ltd. A01, Plant B, No. 278 Hangkong Road Tianjin Pilot Free Trade Zone (Air Port Industrial Park) Tianjin 300308 CN Other 510(k) Applications for this Company
Contact	Ningning Wang Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	FMK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2025
Decision Date	06/26/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review