FDA 510(k) Application Details - K230310

Device Classification Name	More FDA Info for this Device
510(K) Number	K230310
Device Name	STAT Medical Device Lancing System
Applicant	STAT Medical Devices 2056 N.E. 153rd Street North Miami Beach, FL 33162 US Other 510(k) Applications for this Company
Contact	Hemel Mariano 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	02/03/2023
Decision Date	09/08/2023
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