The following data is part of a premarket notification filed by Cox Medical Ent., Inc. with the FDA for Cox Disposable Cytology Brushes.
| Device ID | K912407 |
| 510k Number | K912407 |
| Device Name: | COX DISPOSABLE CYTOLOGY BRUSHES |
| Classification | Endoscopic Cytology Brush |
| Applicant | COX MEDICAL ENT., INC. 2186 EASTMAN AVE. SUITE 110 Ventura, CA 93003 |
| Contact | Lanita Cox |
| Correspondent | Lanita Cox COX MEDICAL ENT., INC. 2186 EASTMAN AVE. SUITE 110 Ventura, CA 93003 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-30 |
| Decision Date | 1991-09-10 |