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510(k) K193499

DigiGuide System by Protomed, Inc. — Product Code DZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2020
Date Received
December 17, 2019
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

Other clearances by Protomed, Inc.

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