K000416 is an FDA 510(k) clearance for the TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001. This device is classified as a Endoilluminator (Class II - Special Controls, product code MPA).
Submitted by Retinalabs.Com (Atlanta, US). The FDA issued a Cleared decision on May 8, 2000, 90 days after receiving the submission on February 8, 2000.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K000416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2000 |
| Decision Date | May 08, 2000 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MPA — Endoilluminator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |