FDA 510(k) Application Details - K220633

Device Classification Name	More FDA Info for this Device
510(K) Number	K220633
Device Name	MICROLET NEXT lancing device, MICROLET Lancet
Applicant	Ascensia Diabetes Care US Inc 5 Wood Hollow Road Parsippany, NJ 07054 US Other 510(k) Applications for this Company
Contact	Sangram Yadav 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	03/04/2022
Decision Date	06/03/2022
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