The following data is part of a premarket notification filed by Mauna Kea Technologies with the FDA for Cellvizio With Confocal Miniprobes, Model F-600; Coloflex And Gastroflex.
| Device ID | K061666 |
| 510k Number | K061666 |
| Device Name: | CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MAUNA KEA TECHNOLOGIES 9, RUE D'ENGHIEN Paris, FR 75010 |
| Contact | Fouad Tarabah |
| Correspondent | Fouad Tarabah MAUNA KEA TECHNOLOGIES 9, RUE D'ENGHIEN Paris, FR 75010 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-14 |
| Decision Date | 2006-08-24 |
| Summary: | summary |