FDA 510(k) Application Details - K230712

Device Classification Name	More FDA Info for this Device
510(K) Number	K230712
Device Name	SG Lanset I, SG Lancets, Soft Lancets
Applicant	Sewon Medical Co. Na-104, 5, Garak-daero 373beon-gil, Gangseo-gu Busan-si 46750 KR Other 510(k) Applications for this Company
Contact	Ji-yeon Kim Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2023
Decision Date	12/06/2023
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