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510(k) K103787

MEDEOR MATRIX by Kensey Nash Corp. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2011
Date Received
December 27, 2010
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 Kensey Nash Corp.

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  • K090919 — KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE (October 2, 2009)
  • K073519 — QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 (March 28, 2008)
  • K071695 — KENSEY NASH MACROPORE SHIELD (December 31, 2007)
  • K072384 — MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE (September 21, 2007)
  • K072195 — THROMCAT THROMBECTOMY CATHETER SYSTEM (August 23, 2007)
  • K071237 — COPIOS BONE VOID FILLER SPONGE AND PASTE (June 1, 2007)
  • K062870 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 (October 20, 2006)
  • K061772 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM (July 11, 2006)

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