The following data is part of a premarket notification filed by Mauna Kea Technologies with the FDA for F-400 System.
| Device ID | K051585 |
| 510k Number | K051585 |
| Device Name: | F-400 SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MAUNA KEA TECHNOLOGIES 9, RUE D'ENGHIEN Paris, FR 75010 |
| Contact | Alexandre Loiseau |
| Correspondent | Alexandre Loiseau MAUNA KEA TECHNOLOGIES 9, RUE D'ENGHIEN Paris, FR 75010 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-15 |
| Decision Date | 2005-09-06 |
| Summary: | summary |