FDA 510(k) K230372, VitreJect Syringe, by Ocuject, LLC
FDA 510(k) K230372, VitreJect Syringe, by Ocuject, LLC
| 510(k) Number | K230372 |
| Device Classification Name | Ophthalmic Syringe |
| Device Name | VitreJect Syringe |
| Applicant | Ocuject, LLC 1441 Avocado Ave. Suite 204 Newport Beach, CA 92660 |
| Regulation Number | 880.586 |
| Classification Product Code | QLY |
| Date Received | 02/13/2023 |
| Decision Date | 09/08/2023 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | General Hospital |
| 510k Review Panel | General Hospital |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 1618 |
| Redacted Pages | 966 |
| Unredacted Pages | 652 |
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