The following data is part of a premarket notification filed by Kitazato Medical Co., Ltd. with the FDA for Iui Catheters.
| Device ID | K112396 |
| 510k Number | K112396 |
| Device Name: | IUI CATHETERS |
| Classification | Catheter, Assisted Reproduction |
| Applicant | KITAZATO MEDICAL CO., LTD. 611 WEST 5TH STREET Austin, TX 78701 |
| Contact | Richard Vincins |
| Correspondent | Richard Vincins KITAZATO MEDICAL CO., LTD. 611 WEST 5TH STREET Austin, TX 78701 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-19 |
| Decision Date | 2012-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14580303269067 | K112396 | 000 |
| 14580303269050 | K112396 | 000 |
| 14580303269043 | K112396 | 000 |
| 14580303269036 | K112396 | 000 |
| 14580303269029 | K112396 | 000 |
| 14580303269012 | K112396 | 000 |