The following data is part of a premarket notification filed by Molnlycke Health Care Us, Llc with the FDA for Avance Foam Dressing Kits.
| Device ID | K141847 |
| 510k Number | K141847 |
| Device Name: | AVANCE FOAM DRESSING KITS |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Contact | Angela L Bunn, Rac |
| Correspondent | Angela L Bunn, Rac 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 | 2014-07-09 |
| Decision Date | 2015-03-26 |
| Summary: | summary |