| Device Classification Name |
Arthroscope
|
| 510(k) Number |
K903312 |
| Device Name |
CYGNASCOPE |
| Applicant |
| Cygnus Instruments, Inc. |
| P.O. Box 60326 |
|
Santa Barbara,
CA
93160
|
|
| Applicant Contact |
E. M FIRST |
| Correspondent |
| Cygnus Instruments, Inc. |
| P.O. Box 60326 |
|
Santa Barbara,
CA
93160
|
|
| Correspondent Contact |
E. M FIRST |
| Regulation Number | 888.1100 |
| Classification Product Code |
|
| Date Received | 07/25/1990 |
| Decision Date | 10/19/1990 |
| 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
|
|
|