AVANCE® FOAM ABDOMINAL DRESSING KIT— 510(k) K130852

Name: FDA 510(k) clearance K130852
Creator: U.S. Food and Drug Administration
Published: 2014-04-14

Substantially Equivalent

Molnlycke Health Care

FDA 510(k) clearance K130852 for AVANCE® FOAM ABDOMINAL DRESSING KIT, Substantially Equivalent on 2014-04-14. Applicant: Molnlycke Health Care. Device class: 2.

Clearance details

Applicant: Molnlycke Health Care
Product code: Code OXJ
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2013-03-28
Decision date: 2014-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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