FDA 510(k) Application Details - K221433

Device Classification Name	More FDA Info for this Device
510(K) Number	K221433
Device Name	Facet 28G Universal Lancet
Applicant	Facet Technologies LLC 3900 N. Commerce Dr. Atlanta, GA 30344 US Other 510(k) Applications for this Company
Contact	James Bonds Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2022
Decision Date	07/15/2022
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