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510(k) K131636

POLARUS CONNECT by Acumed, LLC — Product Code LXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2013
Date Received
June 4, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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