The following data is part of a premarket notification filed by Horizons Intl. Corp. with the FDA for Horizons Ercp Cannula.
| Device ID | K002235 |
| 510k Number | K002235 |
| Device Name: | HORIZONS ERCP CANNULA |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | HORIZONS INTL. CORP. 200 POLITECNICA ST. VILLAS UNIV. PO BOX 250435 Aguadilla, PR 00604 |
| Contact | Rafic Saleh |
| Correspondent | Rafic Saleh HORIZONS INTL. CORP. 200 POLITECNICA ST. VILLAS UNIV. PO BOX 250435 Aguadilla, PR 00604 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-24 |
| Decision Date | 2001-01-23 |