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510(k) K161939

Avance Abdominal Dressing Kit by Molnlycke Health Care Us, LLC — Product Code OXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2016
Date Received
July 14, 2016
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.

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Other clearances for product code OXJ

  • K130852 — AVANCE® FOAM ABDOMINAL DRESSING KIT (April 14, 2014)