Device Classification Name |
Catheter, Assisted Reproduction
|
510(k) Number |
K112396 |
Device Name |
IUI CATHETERS |
Applicant |
KITAZATO MEDICAL CO., LTD. |
611 WEST 5TH STREET |
AUSTIN,
TX
78701
|
|
Applicant Contact |
RICHARD VINCINS |
Correspondent |
KITAZATO MEDICAL CO., LTD. |
611 WEST 5TH STREET |
AUSTIN,
TX
78701
|
|
Correspondent Contact |
RICHARD VINCINS |
Regulation Number | 884.6110
|
Classification Product Code |
|
Date Received | 08/19/2011 |
Decision Date | 11/02/2012 |
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
|
|
|