| Device Classification Name |
Catheter, Assisted Reproduction
|
| 510(k) Number |
K120154 |
| Device Name |
INTRAUTERINE INSEMINATION (IUI) CATHETER |
| Applicant |
| Catheter Research, Inc. |
| 5610 W. 82nd St. |
|
Indianapolis,
IN
46278
|
|
| Applicant Contact |
BABACAR DIOUF |
| Correspondent |
| Catheter Research, Inc. |
| 5610 W. 82nd St. |
|
Indianapolis,
IN
46278
|
|
| Correspondent Contact |
BABACAR DIOUF |
| Regulation Number | 884.6110 |
| Classification Product Code |
|
| Date Received | 01/18/2012 |
| Decision Date | 03/21/2012 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Obstetrics/Gynecology
|
| 510k Review Panel |
Obstetrics/Gynecology
|
| Summary |
Summary
|
| Type |
Abbreviated
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|