FDA 510(k) Application Details - K221521

Device Classification Name	Lancet, Blood   More FDA Info for this Device
510(K) Number	K221521
Device Name	Lancet, Blood
Applicant	SteriLance Medical (Suzhou) Inc. No.168 PuTuoShan Road, New District, Suzhou 215153 CN Other 510(k) Applications for this Company
Contact	Susan Sun Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	FMK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/25/2022
Decision Date	10/28/2022
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