| Device Classification Name |
pump, portable, aspiration (manual or powered)
|
|---|
| 510(K) Number |
K122619 |
|---|
| Model |
C7000, C7100
|
| Device Name |
EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET |
|---|
| Applicant |
| APPLIED MEDICAL |
| 22872 avenida empresa |
|
rancho santa margarita,
CA
92688
|
|
| Contact |
jessica cho |
| Regulation Number | 878.4780
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/28/2012 |
|---|
| Decision Date | 10/02/2012 |
|---|
| 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
|
|---|
|
|
