| Device Classification Name |
Spatula, Orthopedic
|
| 510(k) Number |
K873387 |
| Device Name |
VIDEO ARTHROSCOPE, 1.7MM X 55 MM |
| Applicant |
| Arthropedics, Inc. |
| 111 Lester St. |
|
Wallington,
NJ
07057
|
|
| Applicant Contact |
HERBERT SCHAINHOLZ |
| Correspondent |
| Arthropedics, Inc. |
| 111 Lester St. |
|
Wallington,
NJ
07057
|
|
| Correspondent Contact |
HERBERT SCHAINHOLZ |
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 06/26/1987 |
| Decision Date | 11/25/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|