510(k) K161939
K161939 is an FDA 510(k) premarket notification submitted by Molnlycke Health Care Us, LLC for the device "Avance Abdominal Dressing Kit". The FDA issued a decision of Substantially Equivalent on November 17, 2016. 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 Us, LLC has at least 10 other 510(k) clearances on record.
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.