The following data is part of a premarket notification filed by Felton International, Inc. with the FDA for Human Subcutaneous Injector, Model Hsi 500.
| Device ID | K041280 |
| 510k Number | K041280 |
| Device Name: | HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | FELTON INTERNATIONAL, INC. 200 NE MULBERRY SUITE 200 Lee's Summit, MO 64086 |
| Contact | Jim Stanley |
| Correspondent | Jim Stanley FELTON INTERNATIONAL, INC. 200 NE MULBERRY SUITE 200 Lee's Summit, MO 64086 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-13 |
| Decision Date | 2004-06-24 |
| Summary: | summary |