AVANCE® FOAM ABDOMINAL DRESSING KIT

Mesh, Surgical, Non-absorbable, Large Abdominal Wall Defects

MOLNLYCKE HEALTHCARE

The following data is part of a premarket notification filed by Molnlycke Healthcare with the FDA for Avance® Foam Abdominal Dressing Kit.

Pre-market Notification Details

• Device ID: K130852
• 510k Number: K130852
• Device Name: AVANCE® FOAM ABDOMINAL DRESSING KIT
• Classification: Mesh, Surgical, Non-absorbable, Large Abdominal Wall Defects
• Applicant: MOLNLYCKE HEALTHCARE 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092
• Contact: Angela L Bunn
• Correspondent: Angela L Bunn; MOLNLYCKE HEALTHCARE 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092
• Product Code: OXJ
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-03-28
• Decision Date: 2014-04-14
• Summary: summary