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510(k) K130852

AVANCE® FOAM ABDOMINAL DRESSING KIT by Molnlycke Health Care — Product Code OXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2014
Date Received
March 28, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

For reinforcement of soft tissue where weakness exists in abdominal wall defects.

Other clearances by Molnlycke Health Care

  • K130040 — MEPITEL AG (February 12, 2014)
  • K123892 — MEPILEX TRANSFER AG (April 5, 2013)
  • K122132 — AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LA (January 17, 2013)
  • K102923 — BARRIER N95 PARTICULATE RESPIRATOR (November 19, 2010)
  • K100029 — MEPILEX BORDER AG DRESSING (September 15, 2010)
  • K061554 — MEPILEX AG ABSORBENT SILICONE-COATED DRESSING (January 25, 2007)
  • K062138 — POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPREN (October 5, 2006)
  • K051625 — BARRIER SURGICAL DRAPES (July 14, 2005)
  • K050786 — BARRIER SURGICAL GOWNS (May 9, 2005)
  • K031131 — KLINIDRAPE SURGICAL DRAPES (June 10, 2003)

Other clearances for product code OXJ

  • K161939 — Avance Abdominal Dressing Kit (November 17, 2016)