| Device Classification Name |
negative pressure wound therapy powered suction pump
|
|---|
| 510(K) Number |
K121883 |
|---|
| Model |
CAT. NO: PRE2001US, CAT. NO: PRE2055US
|
| Device Name |
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT |
|---|
| Applicant |
| KCI USA, INC. (KINETIC CONCEPTS, INC.) |
| 6203 farinon drive |
|
san antonio,
TX
78249
|
|
| Contact |
shannon scott |
| Regulation Number | 878.4780
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/09/2012 |
|---|
| Decision Date | 10/11/2012 |
|---|
| 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
|
|---|
