VSP System

Driver, Wire, And Bone Drill, Manual

3D Systems

The following data is part of a premarket notification filed by 3d Systems with the FDA for Vsp System.

Pre-market Notification Details

Device IDK192192
510k NumberK192192
Device Name:VSP System
ClassificationDriver, Wire, And Bone Drill, Manual
Applicant 3D Systems 5381 South Alkire Circle Littleton,  CO  80127
ContactKim Torluemke
CorrespondentKim Torluemke
3D Systems 5381 South Alkire Circle Littleton,  CO  80127
Product CodeDZJ  
CFR Regulation Number872.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-13
Decision Date2020-02-26

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.