The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Cook Fiber Optic Bundle And Flexor Deflecting Access Sheath.
| Device ID | K072521 |
| 510k Number | K072521 |
| Device Name: | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH |
| Classification | Image, Illumination, Fiberoptic, For Endoscope |
| 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 | FFS |
| Subsequent Product Code | FAJ |
| Subsequent Product Code | FED |
| Subsequent Product Code | FGA |
| Subsequent Product Code | FGB |
| Subsequent Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-07 |
| Decision Date | 2007-11-20 |
| Summary: | summary |