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510(k) K151540

MC BIO Supertack Tack 3mm, 4mm and 5mm by Eli-Ka Technologies — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2016
Date Received
June 8, 2015
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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