The following data is part of a premarket notification filed by Molnlycke Health Care Us, Llc with the FDA for Avance Abdominal Dressing Kit.
| Device ID | K161939 |
| 510k Number | K161939 |
| Device Name: | Avance Abdominal Dressing Kit |
| Classification | Mesh, Surgical, Non-absorbable, Large Abdominal Wall Defects |
| Applicant | Molnlycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 |
| Contact | Megan Bevill |
| Correspondent | Megan Bevill Molnlycke Health Care US, LLC 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 | 2016-07-14 |
| Decision Date | 2016-11-17 |
| Summary: | summary |