The following data is part of a premarket notification filed by Molnlycke Health Care Us, Llc with the FDA for Avance Solo Negative Pressure Wound Therapy (npwt) System.
| Device ID | K203369 |
| 510k Number | K203369 |
| Device Name: | Avance Solo Negative Pressure Wound Therapy (NPWT) System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Molnlycke Health Care US, LLC 5445 Triangle Parkway Suite 400 Peachtree Corners, GA 30092 |
| Contact | Megan Bevill |
| Correspondent | Megan Bevill Molnlycke Health Care US, LLC 5445 Triangle Parkway Suite 400 Peachtree Corners, 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 | 2020-11-16 |
| Decision Date | 2021-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07323190310746 | K203369 | 000 |
| 07323190297771 | K203369 | 000 |
| 07323190297573 | K203369 | 000 |
| 07323190310449 | K203369 | 000 |
| 07323190297689 | K203369 | 000 |
| 07323190310531 | K203369 | 000 |
| 07323190297740 | K203369 | 000 |
| 07323190297627 | K203369 | 000 |
| 07323190297801 | K203369 | 000 |
| 07323190295982 | K203369 | 000 |
| 07323190310654 | K203369 | 000 |
| 07323190310685 | K203369 | 000 |
| 07323190310715 | K203369 | 000 |
| 07323190295944 | K203369 | 000 |