The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Urological Biopsy Brush Set.
| Device ID | K770913 |
| 510k Number | K770913 |
| Device Name: | UROLOGICAL BIOPSY BRUSH SET |
| Classification | Endoscopic Cytology Brush |
| Applicant | COOK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-05-19 |
| Decision Date | 1977-06-01 |