The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Cook Odyssey Holmium Laser System, Model 30w.
| Device ID | K080525 |
| 510k Number | K080525 |
| Device Name: | COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W |
| Classification | Powered Laser Surgical Instrument |
| Applicant | COOK UROLOGICAL, INC. 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Cindy Foote |
| Correspondent | Cindy Foote COOK UROLOGICAL, INC. 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-26 |
| Decision Date | 2008-04-17 |
| Summary: | summary |