The following data is part of a premarket notification filed by Iscience Interventional with the FDA for Iscience Interventional Ophthalmic Microcatheter.
| Device ID | K080067 |
| 510k Number | K080067 |
| Device Name: | ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER |
| Classification | Endoilluminator |
| Applicant | ISCIENCE INTERVENTIONAL 4055 CAMPBELL AVENUE Menlo Park, CA 94025 |
| Contact | Grace Bartoo |
| Correspondent | Grace Bartoo ISCIENCE INTERVENTIONAL 4055 CAMPBELL AVENUE Menlo Park, CA 94025 |
| Product Code | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-10 |
| Decision Date | 2008-07-18 |
| Summary: | summary |