The following data is part of a premarket notification filed by Catheter Research, Inc. with the FDA for Intrauterine Insemination (iui) Catheter.
| Device ID | K120154 |
| 510k Number | K120154 |
| Device Name: | INTRAUTERINE INSEMINATION (IUI) CATHETER |
| Classification | Catheter, Assisted Reproduction |
| Applicant | CATHETER RESEARCH, INC. 5610 W 82ND ST Indianapolis, IN 46278 |
| Contact | Babacar Diouf |
| Correspondent | Babacar Diouf CATHETER RESEARCH, INC. 5610 W 82ND ST Indianapolis, IN 46278 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-18 |
| Decision Date | 2012-03-21 |
| Summary: | summary |