| Device Classification Name |
Arthroscope
|
| 510(k) Number |
K941964 |
| Device Name |
LMT ARTHROSCOPIC SUTURING INSTRUMENTS |
| Applicant |
| Li Medical Technologies, Inc. |
| 12 Cambridge Dr. |
|
Trumbull,
CT
06611
|
|
| Applicant Contact |
RHODEMANN LI |
| Correspondent |
| Li Medical Technologies, Inc. |
| 12 Cambridge Dr. |
|
Trumbull,
CT
06611
|
|
| Correspondent Contact |
RHODEMANN LI |
| Regulation Number | 888.1100 |
| Classification Product Code |
|
| Date Received | 04/22/1994 |
| Decision Date | 09/28/1994 |
| 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
|
|
|