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510(k) K970256

INTRAORAL MANDIBULAR DISTRACTION DEVICE by Medicon EG — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1997
Date Received
January 23, 1997
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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