| Device Classification Name |
unit, cryosurgical, accessories |
|||
|---|---|---|---|---|
| 510(k) Number | K111042 | |||
| Device Name | ATRICURE CRYO MODULE | |||
| Applicant |
|
|||
| Applicant Contact | rebecca walters | |||
| Regulation Number | 878.4350 | |||
| Classification Product Code |
|
|||
| Date Received | 04/15/2011 | |||
| Decision Date | 05/26/2011 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
General & Plastic Surgery |
|||
| 510k Review Panel |
Cardiovascular |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | Yes | |||
| Combination Product |
No |