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510(k) K134011

GENERAL SPINAL SYSTEM by Changzhou Dean Medical Instrument Co, Ltd. — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2014
Date Received
December 30, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

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