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510(k) K051946

MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM by Medartis, Inc. — Product Code MQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2005
Date Received
July 18, 2005
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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