The following data is part of a premarket notification filed by Brooke Intl. with the FDA for Cytosmear Brush.
| Device ID | K904160 |
| 510k Number | K904160 |
| Device Name: | CYTOSMEAR BRUSH |
| Classification | System, Abortion, Vacuum |
| Applicant | BROOKE INTL. 3555 LANDFAIR RD. Pasadena, CA 91107 |
| Contact | Todd M Gates |
| Correspondent | Todd M Gates BROOKE INTL. 3555 LANDFAIR RD. Pasadena, CA 91107 |
| Product Code | HHI |
| CFR Regulation Number | 884.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-11 |
| Decision Date | 1990-11-02 |