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510(k) K071695

KENSEY NASH MACROPORE SHIELD by Kensey Nash Corp. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2007
Date Received
June 20, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by Kensey Nash Corp.

  • K103787 — MEDEOR MATRIX (February 7, 2011)
  • K091192 — KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX (November 2, 2009)
  • K091499 — MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) (October 22, 2009)
  • K090919 — KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE (October 2, 2009)
  • K073519 — QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 (March 28, 2008)
  • 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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