FDA 510(k) Application Details - K243533

Device Classification Name	Lancet, Blood   More FDA Info for this Device
510(K) Number	K243533
Device Name	Lancet, Blood
Applicant	HLB Co., Ltd. Healthcare 10-5, Myeonghaksandanseo-ro, Yeondong-myeon Sejong-si 30068 KR Other 510(k) Applications for this Company
Contact	Seung-won Baek 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	11/15/2024
Decision Date	01/13/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review