| Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
|---|
| 510(K) Number |
K120095 |
|---|
| Models |
228203,
228300,
228305,
228370,
228504
|
| Device Name |
SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND |
|---|
| Applicant |
| DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| 325 paramount dr. |
|
raynham,
MA
02767
|
|
| Contact |
susan kagan |
| Regulation Number | 878.4400
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 01/12/2012 |
|---|
| Decision Date | 04/06/2012 |
|---|
| 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
|
|---|
|
|
