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510(k) K083823

SECURIAN TISSUE REINFORCEMENT MATRIX by Xylos Corporation — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2009
Date Received
December 22, 2008
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 Xylos Corporation

  • K111584 — XYLOS MACRO-POROUS SURGICAL MESH (August 25, 2011)
  • K100984 — XYLOS VESSEL GUARD (July 7, 2010)
  • K090880 — XYLOS POROUS SURGICAL MESH (May 27, 2009)
  • K090778 — MTA PROTECTIVE SHEET (April 28, 2009)
  • K081882 — MODIFICATION TO XYLOS SURGICAL MESH (July 11, 2008)
  • K023237 — XYLOS SURGICAL MESH (March 18, 2003)
  • K024054 — XYLOS XCELL ANTIMICROBIAL DRESSING (March 7, 2003)
  • K974251 — X-CELL WOUND DRESSING (June 22, 1998)

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