The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Gift Catheter Set/s.
| Device ID | K983590 |
| 510k Number | K983590 |
| Device Name: | GIFT CATHETER SET/S |
| Classification | Catheter, Assisted Reproduction |
| Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Brenda Davis |
| Correspondent | Brenda Davis COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-13 |
| Decision Date | 1998-12-21 |
| Summary: | summary |