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510(k) K100261

PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD by Tei Biosciences, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2010
Date Received
January 28, 2010
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Tei Biosciences, Inc.

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  • 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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