| Device Classification Name |
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
|
| 510(k) Number |
K874044 |
| Device Name |
INTRA-ARTICULAR ARTHROSCOPIC SHAVER |
| Applicant |
| Medline Industries, Inc. |
| 99 Inverness Dr. E. |
|
Englewood,
CO
80112
|
|
| Applicant Contact |
JO BREHM |
| Correspondent |
| Medline Industries, Inc. |
| 99 Inverness Dr. E. |
|
Englewood,
CO
80112
|
|
| Correspondent Contact |
JO BREHM |
| Regulation Number | 878.4820 |
| Classification Product Code |
|
| Date Received | 10/05/1987 |
| Decision Date | 10/15/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|