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510(k) K140576

Y WIRE 2 by Safewire, LLC — Product Code HXI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 20, 2014
Date Received: March 6, 2014
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Passer, Wire, Orthopedic
Device Class: Class I
Regulation Number: 888.4540
Review Panel: OR
Submission Type