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510(k) K232394

Internal Locking Plate and Screw Fixation System by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2023
Date Received
August 9, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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