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510(k) K023778

DRESSSKIN by Tei Biosciences, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2003
Date Received
November 12, 2002
Clearance Type
Abbreviated
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

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  • K071807 — ORTHOMEND SOFT TISSUE MATRIX (August 6, 2007)
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  • K060829 — COSMATRIX (May 17, 2006)
  • K060984 — XENFORM SOFT TISSUE REPAIR MATRIX (May 17, 2006)

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