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510(k) K133398

STRYKER PEDIATRIC MANDIBLE DISTRACTOR by Stryker — Product Code MQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2014
Date Received
November 6, 2013
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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