| Device Classification Name |
Arthroscope
|
| 510(k) Number |
K992621 |
| Device Name |
ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES |
| Applicant |
| Advanced Diagnostics & Interventions |
| 216 Via Linda Vista |
|
Redondo Beach,
CA
90277
|
|
| Applicant Contact |
ANTONY FENDER |
| Correspondent |
| Advanced Diagnostics & Interventions |
| 216 Via Linda Vista |
|
Redondo Beach,
CA
90277
|
|
| Correspondent Contact |
ANTONY FENDER |
| Regulation Number | 888.1100 |
| Classification Product Code |
|
| Date Received | 08/05/1999 |
| Decision Date | 11/08/1999 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|