The following data is part of a premarket notification filed by Horizons Intl. Corp. with the FDA for Horizons Anso Transbronchial Aspiration Needles.
| Device ID | K022546 |
| 510k Number | K022546 |
| Device Name: | HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES |
| Classification | Bronchoscope (flexible Or Rigid) |
| 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 | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-01 |
| Decision Date | 2002-08-12 |