The following data is part of a premarket notification filed by Horizons Intl. Corp. with the FDA for Horizons International Varices Injection Needles.
| Device ID | K010448 |
| 510k Number | K010448 |
| Device Name: | HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | HORIZONS INTL. CORP. 287 MONTERREY ST. Ponce, PR 00732 |
| Contact | Rafic Saleh |
| Correspondent | Rafic Saleh HORIZONS INTL. CORP. 287 MONTERREY ST. Ponce, PR 00732 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-15 |
| Decision Date | 2001-05-16 |