The following data is part of a premarket notification filed by Horizons Intl. Corp. with the FDA for Horizons Reusable Hot Biopsy Forceps.
| Device ID | K022243 |
| 510k Number | K022243 |
| Device Name: | HORIZONS REUSABLE HOT BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Electric |
| Applicant | HORIZONS INTL. CORP. 287 MONTERREY ST. P.O.BOX 7273 Ponce, PR 00717 |
| Contact | Rafic Saleh |
| Correspondent | Rafic Saleh HORIZONS INTL. CORP. 287 MONTERREY ST. P.O.BOX 7273 Ponce, PR 00717 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-12 |
| Decision Date | 2002-10-25 |