| Device Classification Name |
tunneled catheter remover
|
|---|
| 510(K) Number |
K122263 |
|---|
| Models |
60-0006,
60-0010,
60-0014,
60-0016
|
| Device Name |
14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE |
|---|
| Applicant |
| SYMMETRY MEDICAL |
| 3034 owen drive |
|
antioch,
TN
37013
|
|
| Contact |
hannah foley |
| Regulation Number | 880.5970
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/27/2012 |
|---|
| Decision Date | 09/28/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
General Hospital
|
|---|
| Review Advisory Committee |
General Hospital
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
