The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Cytology Brush.
| Device ID | K780872 |
| 510k Number | K780872 |
| Device Name: | CYTOLOGY BRUSH |
| Classification | Brush, Biopsy, Bronchoscope (non-rigid) |
| Applicant | COOPERVISION, INC. PERMALENS HOUSE 1 BOTLEY ROAD, HEDGE END Southampton, GB S033hb |
| Product Code | BTG |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-05-30 |
| Decision Date | 1978-09-07 |