The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Sydney Ivf Hyaluronidase.
| Device ID | K023353 |
| 510k Number | K023353 |
| Device Name: | SYDNEY IVF HYALURONIDASE |
| Classification | Media, Reproductive |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Debbie Schmitt |
| Correspondent | Debbie Schmitt 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 | 2002-10-07 |
| Decision Date | 2002-12-20 |
| Summary: | summary |