FDA 510(k) Application Details - DEN220078

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220078
Device Name	Eroxon
Applicant	Futura Medical Developments Limited The Surrey Technology Centre 40 Occam Road, Surrey Research Park Guildford GU2 7YG GB Other 510(k) Applications for this Company
Contact	Rachael Hawken Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QWW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/21/2022
Decision Date	06/09/2023
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review