The following data is part of a premarket notification filed by Molnlycke Health Care with the FDA for Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (small, Medium, Large) Avance Transparent Film Avance Foam.
| Device ID | K122132 |
| 510k Number | K122132 |
| Device Name: | AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | MOLNLYCKE HEALTH CARE 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Contact | Angela L Bunn |
| Correspondent | Angela L Bunn MOLNLYCKE HEALTH CARE 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 | 2012-07-18 |
| Decision Date | 2013-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07323190023226 | K122132 | 000 |