The following data is part of a premarket notification filed by Statlab Medical Products, Inc. with the FDA for Cervical Brush.
| Device ID | K884873 |
| 510k Number | K884873 |
| Device Name: | CERVICAL BRUSH |
| Classification | Spatula, Cervical, Cytological |
| Applicant | STATLAB MEDICAL PRODUCTS, INC. 10655 KING WILLIAM Dallas, TX 75220 |
| Contact | Bickel |
| Correspondent | Bickel STATLAB MEDICAL PRODUCTS, INC. 10655 KING WILLIAM Dallas, TX 75220 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-21 |
| Decision Date | 1989-02-09 |