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510(k) K132025

MESO BILAYER SURGICAL MESH by Kensey Nash Corporation Dba Dsm Biomedical — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2013
Date Received
July 1, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

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  • K141738 — MEDEOR MATRIX WOUND DRESSING (February 17, 2015)
  • K133169 — MESO TENDON MATRIX (December 20, 2013)

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