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510(k) K134033

MIROMATRIX BIOLOGICAL MESH by Miromatrix Medical, Inc. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2014
Date Received
December 31, 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

Other clearances by Miromatrix Medical, Inc.

  • K162570 — Miromatrix Biological Mesh TW (February 16, 2017)
  • K160400 — Miromatrix Biological Mesh (June 8, 2016)
  • K150341 — Miromatrix Biological Mesh RS (May 12, 2015)
  • K143426 — Wound Matrix TF (January 27, 2015)
  • K140510 — MIROMATRIX WOUND MATRIX (June 19, 2014)

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