The following data is part of a premarket notification filed by Molnlycke Health Care, Us Llc with the FDA for Avance Foam Dressing Kit - Xl.
| Device ID | K161935 |
| 510k Number | K161935 |
| Device Name: | Avance Foam Dressing Kit - XL |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| 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 | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-14 |
| Decision Date | 2016-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07323190193752 | K161935 | 000 |