The following data is part of a premarket notification filed by Inntec, Inc. with the FDA for Iui Catheter, Model 9057.
| Device ID | K052059 |
| 510k Number | K052059 |
| Device Name: | IUI CATHETER, MODEL 9057 |
| Classification | Catheter, Assisted Reproduction |
| Applicant | INNTEC, INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring INNTEC, INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-29 |
| Decision Date | 2005-11-22 |
| Summary: | summary |