| Device Classification Name |
electrosurgical, cutting & coagulation & accessories |
|||
|---|---|---|---|---|
| 510(k) Number | K081312 | |||
| Device Name | ARAGON ONESHOT SYSTEM | |||
| Applicant |
|
|||
| Applicant Contact | alan curtis | |||
| Correspondent |
|
|||
| Correspodent Contact | alan curtis | |||
| Regulation Number | 878.4400 | |||
| Classification Product Code |
|
|||
| Date Received | 05/09/2008 | |||
| Decision Date | 10/31/2008 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
General & Plastic Surgery |
|||
| 510k Review Panel |
General & Plastic Surgery |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |