FDA 510(k) Application Details - DEN220025

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220025
Device Name	Phagenyx System
Applicant	Phagenesis Limited Unit 18, Enterprise House Pencroft ay, Manchester Science Park Manchester M15 65E GB Other 510(k) Applications for this Company
Contact	Conor Mulrooney Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2022
Decision Date	09/16/2022
Decision	DENG -
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review