| Device Classification Name |
negative pressure wound therapy powered suction pump
|
|---|
| 510(K) Number |
K122132 |
|---|
| Models |
662000,
662151,662251,662351,
664000,
664151,664251,664351
|
| Device Name |
AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM |
|---|
| Applicant |
| MOLNLYCKE HEALTH CARE |
| 5550 peachtree parkway |
| suite 500 |
|
norcross,
GA
30092
|
|
| Contact |
angela l bunn |
| Regulation Number | 878.4780
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/18/2012 |
|---|
| Decision Date | 01/17/2013 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
General & Plastic Surgery
|
|---|
| Review Advisory Committee |
General & Plastic Surgery
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
