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510(k) K062572

CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE by Custom Scientific — Product Code MQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2007
Date Received
August 31, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
External Mandibular Fixator And/Or Distractor
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

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