The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Soft-pass Embryo Mock Transfer Catheter Sets (soft-pass Embryo Mock Transfer Catheter Set And Soft-pass Embryo Mock Transfer Catheter Set With Echogenic Tip).
| Device ID | K191015 |
| 510k Number | K191015 |
| Device Name: | Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set And Soft-Pass Embryo Mock Transfer Catheter Set With Echogenic Tip) |
| Classification | Catheter, Assisted Reproduction |
| Applicant | Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Contact | Ian Herrman |
| Correspondent | Ian Herrman 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 | 2019-04-17 |
| Decision Date | 2019-05-17 |
| Summary: | summary |