| Device Classification Name |
Arthroscope
|
| 510(k) Number |
K946290 |
| Device Name |
CITATION POWER TOOL |
| Applicant |
| Citation Medical Corp. |
| 230 Edison Way |
|
Reno,
NV
89502
|
|
| Applicant Contact |
ROGER KRIEIDBERG |
| Correspondent |
| Citation Medical Corp. |
| 230 Edison Way |
|
Reno,
NV
89502
|
|
| Correspondent Contact |
ROGER KRIEIDBERG |
| Regulation Number | 888.1100 |
| Classification Product Code |
|
| Date Received | 12/27/1994 |
| Decision Date | 06/15/1995 |
| 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
|
|
|