The following data is part of a premarket notification filed by Felton International, Inc. with the FDA for Bi-3m Needle-free Injector System.
| Device ID | K013256 |
| 510k Number | K013256 |
| Device Name: | BI-3M NEEDLE-FREE INJECTOR SYSTEM |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | FELTON INTERNATIONAL, INC. 8210 MARSHALL DR. Lenexa, KS 66214 |
| Contact | Alan Felton |
| Correspondent | Alan Felton FELTON INTERNATIONAL, INC. 8210 MARSHALL DR. Lenexa, KS 66214 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-01 |
| Decision Date | 2001-12-07 |
| Summary: | summary |