The following data is part of a premarket notification filed by 3d Systems with the FDA for Vsp System.
Device ID | K192192 |
510k Number | K192192 |
Device Name: | VSP System |
Classification | Driver, Wire, And Bone Drill, Manual |
Applicant | 3D Systems 5381 South Alkire Circle Littleton, CO 80127 |
Contact | Kim Torluemke |
Correspondent | Kim Torluemke 3D Systems 5381 South Alkire Circle Littleton, CO 80127 |
Product Code | DZJ |
CFR Regulation Number | 872.4120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-13 |
Decision Date | 2020-02-26 |