The following data is part of a premarket notification filed by Medgyn Products, Inc. with the FDA for Medgyn Straight Iui Catheter, Medgyn Mini Iui Catheter, Medgyn Curved, Mini Iui Catheter.
| Device ID | K143669 |
| 510k Number | K143669 |
| Device Name: | MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn Curved, Mini IUI Catheter |
| Classification | Catheter, Assisted Reproduction |
| Applicant | MEDGYN PRODUCTS, INC. 100 W. Industrial Rd. Addison, IL 60101 |
| Contact | Amar Agadi |
| Correspondent | Amar Agadi MEDGYN PRODUCTS, INC. 100 W. Industrial Rd. Addison, IL 60101 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-11-23 |
| Summary: | summary |