| Device Classification Name |
powered laser surgical instrument |
|||
|---|---|---|---|---|
| 510(k) Number | K992374 | |||
| Device Name | AURORA HL | |||
| Applicant |
|
|||
| Applicant Contact | beth a roberts | |||
| Correspondent |
|
|||
| Correspodent Contact | beth a roberts | |||
| Regulation Number | 878.4810 | |||
| Classification Product Code |
|
|||
| Date Received | 07/15/1999 | |||
| Decision Date | 09/22/1999 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
General & Plastic Surgery |
|||
| 510k Review Panel |
General & Plastic Surgery |
|||
| statement |
statement |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |