Avance Abdominal Dressing Kit— 510(k) K161939

Name: FDA 510(k) clearance K161939
Creator: U.S. Food and Drug Administration
Published: 2016-11-17

Substantially Equivalent

Molnlycke Health Care Us, LLC

FDA 510(k) clearance K161939 for Avance Abdominal Dressing Kit, Substantially Equivalent on 2016-11-17. Applicant: Molnlycke Health Care Us, LLC. Device class: 2.

Clearance details

Applicant: Molnlycke Health Care Us, LLC
Product code: Code OXJ
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2016-07-14
Decision date: 2016-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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