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510(k) K162965

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction by Tei Biosciences, Inc. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2017
Date Received
October 24, 2016
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 Tei Biosciences, Inc.

  • K153690 — PriMatrix Dermal Repair Scaffold (February 22, 2016)
  • K131286 — PRIMATRIX DERMAL REPAIR SCAFFOLD (August 5, 2013)
  • K100261 — PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD (December 10, 2010)
  • K083898 — SURGIMEND (February 4, 2009)
  • K083440 — PRIMATRIX DERMAL REPAIR SCAFFOLD (December 12, 2008)
  • K071807 — ORTHOMEND SOFT TISSUE MATRIX (August 6, 2007)
  • K061407 — PRIMATRIX DERMAL REPAIR SCAFFOLD (June 29, 2006)
  • K060829 — COSMATRIX (May 17, 2006)
  • K060984 — XENFORM SOFT TISSUE REPAIR MATRIX (May 17, 2006)
  • K060989 — TISSUEMEND SOFT TISSUE REPAIR MATRIX (May 15, 2006)

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