The following data is part of a premarket notification filed by D'antonio Consultants International, Inc. (dci) with the FDA for Lectrajet Needle-free Injection System, Model: M3 Ra.
| Device ID | K090959 |
| 510k Number | K090959 |
| Device Name: | LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | D'ANTONIO CONSULTANTS INTERNATIONAL, INC. (DCI) 6308 FLY RD. East Syracuse, NY 13057 |
| Contact | Joseph P D'antonio |
| Correspondent | Joseph P D'antonio D'ANTONIO CONSULTANTS INTERNATIONAL, INC. (DCI) 6308 FLY RD. East Syracuse, NY 13057 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-06 |
| Decision Date | 2009-12-24 |
| Summary: | summary |