The following data is part of a premarket notification filed by Medi-ject Corp. with the FDA for Medi-jector Choice Needle-free Insulin Delivery System.
| Device ID | K962956 |
| 510k Number | K962956 |
| Device Name: | MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | MEDI-JECT CORP. 1840 BERKSHIRE LN. Minneapolis, MN 55441 |
| Contact | Peter L Sadowski |
| Correspondent | Peter L Sadowski MEDI-JECT CORP. 1840 BERKSHIRE LN. Minneapolis, MN 55441 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-30 |
| Decision Date | 1996-10-07 |
| Summary: | summary |