| Device Classification Name |
system, ablation, microwave and accessories
|
|---|
| 510(K) Number |
K122762 |
|---|
| Model |
ACCU2I PART NO.'S 900-600,900-601,900-602
|
| Device Name |
ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR |
|---|
| Applicant |
| MICROSULIS MEDICAL LIMITED |
| unit 1 and 2 falson court |
| parklands business park |
|
denmead,
|
|
| Contact |
stuart mcintyre |
| Regulation Number | 878.4400
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 09/10/2012 |
|---|
| Decision Date | 11/30/2012 |
|---|
| 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
|
|---|
