The following data is part of a premarket notification filed by Horizons Intl. Corp. with the FDA for Tornado Rotatabel Snare And Polyp Catcher.
| Device ID | K083049 |
| 510k Number | K083049 |
| Device Name: | TORNADO ROTATABEL SNARE AND POLYP CATCHER |
| Classification | Snare, Flexible |
| Applicant | HORIZONS INTL. CORP. P.O. BOX 213-3006 ZONA FRANCA METRO Barreal De Heredia, CR |
| Contact | Rafic Saleh |
| Correspondent | Rafic Saleh HORIZONS INTL. CORP. P.O. BOX 213-3006 ZONA FRANCA METRO Barreal De Heredia, CR |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-14 |
| Decision Date | 2008-12-23 |