FDA 510(k) Application Details - K230015

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K230015
Device Name	Instrument, Biopsy
Applicant	Laurane Medical SAS Chemin de la bayette ZAC de la bayette Le Pradet 83220 FR Other 510(k) Applications for this Company
Contact	Laurent Fumex Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	KNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/03/2023
Decision Date	06/16/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review