The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Berger Prostate Culture Cytology Brush.
| Device ID | K880095 |
| 510k Number | K880095 |
| Device Name: | BERGER PROSTATE CULTURE CYTOLOGY BRUSH |
| Classification | Endoscopic Cytology Brush |
| Applicant | VAN-TEC, INC. P.O. BOX 26 Spencer, IN 47460 |
| Contact | Vance, Jr. |
| Correspondent | Vance, Jr. VAN-TEC, INC. P.O. BOX 26 Spencer, IN 47460 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-12 |
| Decision Date | 1988-03-02 |