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510(k) K133525

LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM by Changzhou Dean Medical Instrument Co, Ltd. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2014
Date Received
November 15, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Changzhou Dean Medical Instrument Co, Ltd.

  • K134011 — GENERAL SPINAL SYSTEM (September 3, 2014)

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