FDA 510(k) Application Details - K231797

Device Classification Name	More FDA Info for this Device
510(K) Number	K231797
Device Name	Medifun Lancing Device, Model No. LD-E1
Applicant	Medifun Corporation 4F-1, 4F-9, 4F-10, No.99, Jingke S. Rd., Nantun Dist. Taichung 408 TW Other 510(k) Applications for this Company
Contact	Aaron Chen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2023
Decision Date	11/22/2023
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