| Device Classification Name |
Neurological Stereotaxic Instrument
|
|---|
| 510(k) Number |
K113228 |
|---|
| Device Name |
RENAISSANCE SYSTEM |
|---|
| Applicant |
| Mazor Robotics , Ltd. |
| 20 Hata'As St. |
|
Kfar Saba,
IL
44425
|
|
| Applicant Contact |
AHAVA STEIN |
| Correspondent |
| Mazor Robotics , Ltd. |
| 20 Hata'As St. |
|
Kfar Saba,
IL
44425
|
|
| Correspondent Contact |
AHAVA STEIN |
| Regulation Number | 882.4560 |
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 11/01/2011 |
|---|
| Decision Date | 12/01/2011 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Neurology
|
|---|
| 510k Review Panel |
Radiology
|
|---|
| Summary |
Summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|