The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Detect (tm) Cytology Brush.
| Device ID | K933415 |
| 510k Number | K933415 |
| Device Name: | DETECT (TM) CYTOLOGY BRUSH |
| Classification | Spatula, Cervical, Cytological |
| Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Tammy Bacon |
| Correspondent | Tammy Bacon COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-13 |
| Decision Date | 1994-02-25 |