| Device Classification Name |
Arthroscope
|
| 510(k) Number |
K860607 |
| Device Name |
MARKOPTIC IMPROVED ARTHROSCOPE |
| Applicant |
| Markoptic |
| 2329 N.Bosworth |
|
Chicago,
IL
60614
|
|
| Applicant Contact |
MARKO VUKOVIC |
| Correspondent |
| Markoptic |
| 2329 N.Bosworth |
|
Chicago,
IL
60614
|
|
| Correspondent Contact |
MARKO VUKOVIC |
| Regulation Number | 888.1100 |
| Classification Product Code |
|
| Date Received | 02/19/1986 |
| Decision Date | 03/05/1986 |
| 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
|
|
|