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510(k) K192561

TRAUS SUS20 by Saeshin Precision Co., Ltd. — Product Code DZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2020
Date Received
September 17, 2019
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

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