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510(k) K201292

TRAUS SIP20 by Saeshin Precision Co., Ltd. — Product Code EBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2021
Date Received
May 14, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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