The following data is part of a premarket notification filed by Alcon Research, Ltd. with the FDA for Hypervit Vitrectomy Probe, 23 Ga, Hypervit Vitrectomy Probe, 25+, Hypervit Vitrectomy Probe, 27+.
| Device ID | K170520 |
| 510k Number | K170520 |
| Device Name: | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ |
| Classification | Vitrectomy, Instrument Cutter |
| Applicant | Alcon Research, Ltd. 20511 Lake Forest Drive Lake Forest, CA 92630 |
| Contact | Karen Mudd |
| Correspondent | Karen Mudd Alcon Research, Ltd. 20511 Lake Forest Drive Lake Forest, CA 92630 |
| Product Code | MLZ |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-22 |
| Decision Date | 2017-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10380658300231 | K170520 | 000 |
| 10380658300224 | K170520 | 000 |
| 10380658300279 | K170520 | 000 |
| 10380658300262 | K170520 | 000 |
| 10380658300774 | K170520 | 000 |
| 10380657531094 | K170520 | 000 |
| 10380657531063 | K170520 | 000 |
| 10380650000962 | K170520 | 000 |
| 10380650000955 | K170520 | 000 |