| Device Classification Name |
electrosurgical, cutting & coagulation & accessories |
|||
|---|---|---|---|---|
| 510(k) Number | K013680 | |||
| Device Name | CARBODISSECTING ENDOSCOPE | |||
| Original Applicant |
|
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| Original Contact | debbie iampietro | |||
| Regulation Number | 878.4400 | |||
| Classification Product Code |
|
|||
| Subsequent Product Code |
|
|||
| Date Received | 11/07/2001 | |||
| Decision Date | 03/04/2002 | |||
| 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 |