| Device Classification Name |
Arthroscope
|
| 510(k) Number |
K900609 |
| Device Name |
SHEPPERD STRAIGHT AND CURVED NEEDLES |
| Applicant |
| Downs Surgical , Ltd. |
| Pkwy. Close,Pkwy. |
| Industrial Estate |
|
Sheffield S9 4wj,
GB
|
|
| Applicant Contact |
J NEWSON |
| Correspondent |
| Downs Surgical , Ltd. |
| Pkwy. Close,Pkwy. |
| Industrial Estate |
|
Sheffield S9 4wj,
GB
|
|
| Correspondent Contact |
J NEWSON |
| Regulation Number | 888.1100 |
| Classification Product Code |
|
| Date Received | 02/08/1990 |
| Decision Date | 10/22/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|