510(k) K150076

Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L by Dong IL Technology , Ltd. — Product Code DZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2015
Date Received
January 14, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Bone, Powered
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type