The following data is part of a premarket notification filed by Kaneka Corp. with the FDA for Trimotion Injector.
| Device ID | K102999 |
| 510k Number | K102999 |
| Device Name: | TRIMOTION INJECTOR |
| Classification | Graft Insertion Instrument For Endothelial Keratoplasty |
| Applicant | KANEKA CORP. 5-1-1, TORIKAI-NISHI Settsu, Osaka, JP 566-0072 |
| Contact | Tamiji Fujimoto |
| Correspondent | Tamiji Fujimoto KANEKA CORP. 5-1-1, TORIKAI-NISHI Settsu, Osaka, JP 566-0072 |
| Product Code | OTZ |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-08 |
| Decision Date | 2011-12-29 |
| Summary: | summary |