The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, And Cook Ivf Sperm Gradient Kit.
| Device ID | K002383 |
| 510k Number | K002383 |
| Device Name: | COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT |
| Classification | Media, Reproductive |
| 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 | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-04 |
| Decision Date | 2000-09-13 |