The following data is part of a premarket notification filed by Mauna Kea Technologies with the FDA for Cystoflex Uhd R-c, Celioflex Uhd 5-c, Cellvizio 100 Series (800) With Confocal Miniprobes.
| Device ID | K160416 |
| 510k Number | K160416 |
| Device Name: | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) With Confocal Miniprobes |
| Classification | Confocal Optical Imaging |
| Applicant | MAUNA KEA TECHNOLOGIES 9, RUE D'ENGHIEN Paris, FR 75010 |
| Contact | Veronique Dentan |
| Correspondent | Michael A. Daniel DANIEL & DANIEL CONSULTING 340 JONES LANE Gardenville, NV 89460 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-16 |
| Decision Date | 2016-05-20 |
| Summary: | summary |