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510(k) K160991

Neo GBR System by Neobiotech Co., Ltd. — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2017
Date Received
April 8, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Intraosseous
Device Class
Class II
Regulation Number
872.4880
Review Panel
DE
Submission Type

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