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510(k) K092743

THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM by Stryker Craniomaxillofacial — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2010
Date Received
September 8, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

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