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510(k) K100785

BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES by Bonart Co., Ltd. — Product Code EBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2010
Date Received
March 19, 2010
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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