FDA 510(k) Application Details - K243143

Device Classification Name	More FDA Info for this Device
510(K) Number	K243143
Device Name	E-PEN (E-PEN)
Applicant	BOMTECH ELECTRONICS CO., LTD. 322, Gonghang-daero, Gangseo-gu Seoul KR Other 510(k) Applications for this Company
Contact	Lee Junseok Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2024
Decision Date	04/07/2025
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