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510(k) K143426

Wound Matrix TF by Miromatrix Medical, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2015
Date Received
December 1, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
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)
  • K140510 — MIROMATRIX WOUND MATRIX (June 19, 2014)
  • K134033 — MIROMATRIX BIOLOGICAL MESH (March 31, 2014)

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