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510(k) K220360

Tandry CMF Plate System by Microware Precision Co., Ltd. — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2022
Date Received
February 8, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

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