FDA 510(k) Application Details - K232216

Device Classification Name	More FDA Info for this Device
510(K) Number	K232216
Device Name	Hemoblock_S (Prescription); Hemoblock_S (OTC)
Applicant	Incore Co., Ltd. 11, Hyeoksin-daero, 78-gil, Dong-gu Daegu 41072 KR Other 510(k) Applications for this Company
Contact	Jae-Hun Lee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2023
Decision Date	04/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review