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510(k) K151083

BioBridge Collagen Matrix by Fibralign Corporation — Product Code OWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2016
Date Received
April 22, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

For reinforcement of soft tissue where weakness exists in tendon repair.

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