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510(k) K163651

ExpressBraid Graft Manipulation by Biomet Manufacturing Corp — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2017
Date Received
December 23, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

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