| Device Classification Name |
laparoscopic single port access device
|
|---|
| 510(K) Number |
K121309 |
|---|
| Model |
WA58010Q
|
| Device Name |
ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE |
|---|
| Applicant |
| ADVANCED SURGICAL CONCEPTS |
| 355 thirteenth street, nw |
| columbia square |
|
washington,
DC
20004
|
|
| Contact |
jonathan kahan |
| Regulation Number | 876.1500
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 05/01/2012 |
|---|
| Decision Date | 09/06/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
General & Plastic Surgery
|
|---|
| Review Advisory Committee |
General & Plastic Surgery
|
|---|
| summary |
summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
