Device Classification Name |
Catheter, Assisted Reproduction
|
510(k) Number |
K092579 |
Device Name |
INTRAUTERINE INSEMINATION (IUI) CATHETER |
Applicant |
FERTILIGENT, LTD |
5610 W 82ND ST |
INDIANAPOLIS,
IN
46278
|
|
Applicant Contact |
JOHN A STEEN |
Correspondent |
FERTILIGENT, LTD |
5610 W 82ND ST |
INDIANAPOLIS,
IN
46278
|
|
Correspondent Contact |
JOHN A STEEN |
Regulation Number | 884.6110
|
Classification Product Code |
|
Date Received | 08/17/2009 |
Decision Date | 04/02/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|