The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Shepard, Insemi-cath, And Soft-pass Coaxial - Cook Intrauterine Insemination Catheters.
| Device ID | K172321 |
| 510k Number | K172321 |
| Device Name: | Shepard, Insemi-Cath, And Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters |
| Classification | Catheter, Assisted Reproduction |
| Applicant | Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Contact | Naomi Funkhouser |
| Correspondent | Naomi Funkhouser Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-01 |
| Decision Date | 2017-12-21 |
| Summary: | summary |