FDA 510(k) Application Details - K221546

Device Classification Name	More FDA Info for this Device
510(K) Number	K221546
Device Name	OneTouch Delica Plus Lancing System
Applicant	Asahi Polyslider Co., Ltd. 860-2 Misaki Maniwa 719-3226 JP Other 510(k) Applications for this Company
Contact	Yoshitaka Akagi 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	05/27/2022
Decision Date	08/23/2022
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