| Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
|---|
| 510(K) Number |
K122425 |
|---|
| Models |
225370,
227355,
227504,
228370,
228504
|
| Device Name |
VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT |
|---|
| Applicant |
| DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| 325 paramount dr. |
|
raynham,
MA
02767
|
|
| Contact |
yayoi fujimaki |
| Regulation Number | 878.4400
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/09/2012 |
|---|
| Decision Date | 11/05/2012 |
|---|
| 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
|
|---|
