The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Cook Wire Guides.
| Device ID | K082536 |
| 510k Number | K082536 |
| Device Name: | COOK WIRE GUIDES |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
| Contact | Cindy Foote |
| Correspondent | Cindy Foote COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-02 |
| Decision Date | 2008-10-27 |
| Summary: | summary |