The following data is part of a premarket notification filed by Carl Zeiss Meditec Cataract Technology Inc with the FDA for Xport 304 (micor) System Lens Fragmentation System.
| Device ID | K200584 |
| 510k Number | K200584 |
| Device Name: | XPORT 304 (miCOR) System Lens Fragmentation System |
| Classification | Unit, Phacofragmentation |
| Applicant | Carl Zeiss Meditec Cataract Technology Inc 8748 Technology Way Reno, NV 89521 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik Carl Zeiss Meditec Cataract Technology Inc 8748 Technology Way Reno, NV 89521 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-06 |
| Decision Date | 2020-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30860000122376 | K200584 | 000 |
| 10860000122365 | K200584 | 000 |
| 00850005541042 | K200584 | 000 |