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510(k) K220648

OMF ASP System by Vha Dean — Product Code DZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2022
Date Received
March 7, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Driver, Wire, And Bone Drill, Manual
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

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