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510(k) K020455

TISSUEMEND SOFT TISSUE REPAIR MATRIX by Tei Biosciences, Inc. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2002
Date Received
February 11, 2002
Clearance Type
Abbreviated
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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  • 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)

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