The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Sydney Ivf Culture Oil.
| Device ID | K022002 |
| 510k Number | K022002 |
| Device Name: | SYDNEY IVF CULTURE OIL |
| Classification | Media, Reproductive |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Brenda Davis |
| Correspondent | Brenda Davis COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 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 | 2002-06-19 |
| Decision Date | 2002-08-12 |
| Summary: | summary |