The following data is part of a premarket notification filed by Fertiligent, Ltd with the FDA for Fertiligent Slow Release Iui Catheter Kit.
| Device ID | K141666 |
| 510k Number | K141666 |
| Device Name: | FERTILIGENT SLOW RELEASE IUI CATHETER KIT |
| Classification | Catheter, Assisted Reproduction |
| Applicant | FERTILIGENT, LTD 5610 W 82ND ST Indianapolis, IN 46278 |
| Contact | Babacar Diouf |
| Correspondent | Babacar Diouf FERTILIGENT, LTD 5610 W 82ND ST Indianapolis, IN 46278 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-23 |
| Decision Date | 2015-02-03 |
| Summary: | summary |