FDA 510(k) Application Details - K221970

Device Classification Name	More FDA Info for this Device
510(K) Number	K221970
Device Name	Lancing device
Applicant	SteriLance Medical(Suzhou) Inc. No.168 PuTuoShan Road Suzhou 215153 CN Other 510(k) Applications for this Company
Contact	Susan Sun 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	07/05/2022
Decision Date	08/30/2022
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