510(k) K130852
K130852 is an FDA 510(k) premarket notification submitted by Molnlycke Health Care for the device "AVANCE® FOAM ABDOMINAL DRESSING KIT". The FDA issued a decision of Substantially Equivalent on April 14, 2014. The device falls under product code OXJ (Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects), a Class II device regulated under 21 CFR 878.3300. Molnlycke Health Care has at least 10 other 510(k) clearances on record.
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.