| Device Classification Name |
unit, cryosurgical, accessories |
||||
|---|---|---|---|---|---|
| 510(k) Number | K131523 | ||||
| Device Name | CRYOBALLOON FOCAL ABLATION SYSTEM | ||||
| Applicant |
|
||||
| Applicant Contact | peter garcia-meza | ||||
| Correspondent |
|
||||
| Correspodent Contact | peter garcia-meza | ||||
| Regulation Number | 878.4350 | ||||
| Classification Product Code |
|
||||
| Date Received | 05/28/2013 | ||||
| Decision Date | 08/22/2013 | ||||
| Decision |
substantially equivalent (SESE) |
||||
| Regulation Medical Specialty |
General & Plastic Surgery |
||||
| 510k Review Panel |
General & Plastic Surgery |
||||
| summary |
summary |
||||
| Type | Special | ||||
| Reviewed by Third Party | No | ||||
| Combination Product |
No |