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510(k) K092758

X-CUBE by Saeshin Precision Co., Ltd. — Product Code EBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2009
Date Received
September 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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