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510(k) K213749

G7, Dental Operative Unit and Accessories by Shinhung Company, Ltd. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2023
Date Received
November 30, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

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