FDA 510(k) Application Details - K181756

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K181756
Device Name	Kit, Needle, Biopsy
Applicant	AprioMed AB Virdings Alle 28 Uppsala 75450 SE Other 510(k) Applications for this Company
Contact	Katrin Svensson Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	FCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2018
Decision Date	12/18/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review