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510(k) K083898

SURGIMEND by Tei Biosciences, Inc. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2009
Date Received
December 29, 2008
Clearance Type
Special
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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  • 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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