| Device Classification Name |
arthroscope |
|||
|---|---|---|---|---|
| 510(k) Number | K121893 | |||
| Device Name | STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM | |||
| Applicant |
|
|||
| Applicant Contact | lifei liu | |||
| Regulation Number | 888.1100 | |||
| Classification Product Code |
|
|||
| Subsequent Product Code |
|
|||
| Date Received | 06/29/2012 | |||
| Decision Date | 09/05/2012 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Orthopedic |
|||
| 510k Review Panel |
General & Plastic Surgery |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | Yes | |||
| Combination Product |
No |