| Device Classification Name |
coil, magnetic resonance, specialty
|
|---|
| 510(k) Number |
K000589 |
|---|
| Device Name |
MODEL 445SI-64E QUADRATURE WRIST COIL |
|---|
| Applicant |
| IGC-MEDICAL ADVANCES, INC. |
| 10437 INNOVATION DR. |
|
MILWAUKEE,
WI
53226
|
|
| Applicant Contact |
THOMAS E TYNES |
| Correspondent |
| IGC-MEDICAL ADVANCES, INC. |
| 10437 INNOVATION DR. |
|
MILWAUKEE,
WI
53226
|
|
| Correspondent Contact |
THOMAS E TYNES |
| Regulation Number | 892.1000
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 02/22/2000 |
|---|
| Decision Date | 03/14/2000 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Radiology
|
|---|
| 510k Review Panel |
Radiology
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|