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510(k) K111623

I-ENDO DUAL by Satelec - Acteon Group — Product Code EBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2012
Date Received
June 10, 2011
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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