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510(k) K153285

EMS-200 by Meta Systems Co., Ltd. — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2016
Date Received
November 12, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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