| Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
|---|
| 510(K) Number |
K121306 |
|---|
| Models |
OM-8000,
OM-8017,
OM-8175,
OM-8176,
OM-8177
|
| Device Name |
SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE |
|---|
| Applicant |
| ARTHOCARE CORPORATION |
| 7000 west william cannon drive |
| building one |
|
austin,
TX
78735
|
|
| Contact |
cheryl frederick |
| Regulation Number | 878.5000
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 05/07/2012 |
|---|
| Decision Date | 07/12/2012 |
|---|
| 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
|
|---|
|
|
