| Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
|
| 510(k) Number |
K960448 |
| Device Name |
LM ANCHOR |
| Applicant |
| Li Medical Technologies, Inc. |
| 4 Armstrong Rd. |
|
Shelton,
CT
06484
|
|
| Applicant Contact |
RHODEMANN LI |
| Correspondent |
| Li Medical Technologies, Inc. |
| 4 Armstrong Rd. |
|
Shelton,
CT
06484
|
|
| Correspondent Contact |
RHODEMANN LI |
| Regulation Number | 888.3040 |
| Classification Product Code |
|
| Date Received | 01/30/1996 |
| Decision Date | 04/17/1996 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|