FDA 510(k) Application Details - K220366

Device Classification Name	Driver, Wire, And Bone Drill, Manual   More FDA Info for this Device
510(K) Number	K220366
Device Name	Driver, Wire, And Bone Drill, Manual
Applicant	3D LifePrints UK Ltd. The Innovation Hub, Alder Hey Children's NHS Foundation Trust, Eaton Road West Derby, Liverpool, Merseyside L12 2AP GB Other 510(k) Applications for this Company
Contact	Henry Pinchbeck Other 510(k) Applications for this Contact
Regulation Number	872.4120   More FDA Info for this Regulation Number
Classification Product Code	DZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2022
Decision Date	09/30/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review