The following data is part of a premarket notification filed by Horizons Intl. Corp. with the FDA for Horizons Cytology Brush.
| Device ID | K021998 |
| 510k Number | K021998 |
| Device Name: | HORIZONS CYTOLOGY BRUSH |
| Classification | Endoscopic Cytology Brush |
| Applicant | HORIZONS INTL. CORP. P.O. BOX 7273 Ponce, PR 00732 -7273 |
| Contact | Rafic Saleh |
| Correspondent | Rafic Saleh HORIZONS INTL. CORP. P.O. BOX 7273 Ponce, PR 00732 -7273 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-19 |
| Decision Date | 2002-07-12 |