Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K192192
Device Classification Name
Driver, Wire, And Bone Drill, Manual
More FDA Info for this Device
510(K) Number
K192192
Device Name
Driver, Wire, And Bone Drill, Manual
Applicant
3D Systems
5381 South Alkire Circle
Littleton, CO 80127 US
Other 510(k) Applications for this Company
Contact
Kim Torluemke
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
08/13/2019
Decision Date
02/26/2020
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact