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510(k) K133169

MESO TENDON MATRIX by Kensey Nash Corporation Dba Dsm Biomedical — Product Code OWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2013
Date Received
October 17, 2013
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.

Other clearances by Kensey Nash Corporation Dba Dsm Biomedical

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  • K170245 — DSM Biomedical Dental Bone Graft (May 16, 2017)
  • K160474 — DSM Biomedical Porcine Pericardium Dental Membrane (June 7, 2016)
  • K141738 — MEDEOR MATRIX WOUND DRESSING (February 17, 2015)
  • K132025 — MESO BILAYER SURGICAL MESH (October 30, 2013)

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